Carcinoma, Squamous Cell of Head and Neck, Oropharynx Squamous Cell Carcinoma
Conditions
Keywords
Oropharynx Cancer, OPSCC, Nivolumab, Adjuvant therapy, De-Escalated Radiation, Squamous cell carcinoma, P16+, Head and Neck cancer, Oropharynx Squamous Cell Carcinoma, Carcinoma, Squamous Cell of Head and Neck, Transoral surgery, Radiotherapy
Brief summary
This clinical trial will evaluate a new combination of treatments for Oropharyngeal Squamous Cell cancers (OPSCC), and compare it to the current standard of care (concurrent, platinum-based chemoradiotherapy). Chemoradiotherapy is efficacious, but also associated with significant toxicities and is only suitable for patients with good performance status and without severe comorbidities. The purpose of this trial is to demonstrate equivalent oncologic outcome with fewer adverse effects and improved quality of life when compared to the standard of care.
Detailed description
This study aims to enroll 135 patients (male and female, age 18+) who are newly diagnosed with resectable, squamous cell carcinoma or undifferentiated carcinoma of the oropharynx. Survival rate and treatment response of OPSCC varies based on HPV infection status and genotype; therefore, in this study, only patients who are HPV seropositive and have HPV type 16 will be enrolled. All patients will receive the same treatment, i.e. there is no active control group. In this trial, patients will undergo transoral surgery followed by de-intensified adjuvant radiotherapy plus nivolumab. The radiotherapy will consist of 45 or 50 Gy (depending on tumor volume) in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at a fixed dose of 240 mg over 30 minutes IV every 2 weeks during radiotherapy, and at 480 mg over 60 minutes IV every 4 weeks for 6 doses after radiotherapy. The first dose will be given prior to the first fraction of radiation (Day 1) on Day -3 (+/- 2 days), and continued every 2 weeks (+/- 2 days). Nivolumab will thus be given in weeks 2 and 4 of radiotherapy. Adjuvant nivolumab will then be given for a total of 6 additional doses after the completion of radiotherapy every 4 weeks (+/- 7 days), starting in the second or third week after the completion of radiotherapy. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment. Relevant outcome measures include disease free survival (2 year post surgery); percutaneous gastronomy dependence (1-year postsurgery); acute and late toxicity; patient-reported Quality of Life measures, locoregional control and distant metastatic control.
Interventions
A fully human anti-programmed death 1 (PD-1) monoclonal antibody
RADIATIONRadiotherapy (RT)
45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week
Sponsors
Bristol-Myers Squibb
Robert L. Ferris, MD, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>/= 18 years. * ECOG performance status of 0 or 1. * Patients must have newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx. Patients must have been determined to have resectable oropharyngeal disease. Patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible. * Patients must have intermediate risk factors, as described below as determined by imaging studies (performed \< 45 days prior to registration) and complete neck exam, from the skull base to the clavicles. The following imaging is required: CT scan of neck only with IV contrast or MRI. PET scan of HN and chest with IV contrasted CT correlation is encouraged prior to enrollment. Intermediate risk features: Tobacco \<10 pk-yr: T0-3 plus any one of the following: \>N2b (\> 5 LN's +), N2c/N3, +ENE \>1 mm, or + margin (if approved by surgical chair) OR Tobacco \>10 pk-yr: T0-3 plus any one of the following: any N2, N3, +ENE \>1 mm, or + margin (if approved by surgical chair) * Patients must have no evidence of distant metastases (M0) * Patients must have biopsy-proven p16+ oropharynx cancer; the histologic evidence of invasive squamous cell carcinoma may have been obtained from the primary tumor or metastatic lymph node. It is required that patients have a positive p16 IHC (as surrogate for HPV) status from either the primary tumor or metastatic lymph node. * Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a CLIA approved laboratory. * No prior radiation above the clavicles. * Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of cervix, differentiated thyroid cancer, melanoma in-situ (if fully resected), and/or non-melanomatous skin cancer, or clinically negligible in judgement of investigator. * Patients with the following within the last 6 months prior to registration must be evaluated by a cardiologist and / or neurologist prior to entry into the study. * Congestive heart failure \> NYHA Class II * CVA / TIA * Unstable angina * Myocardial infarction (with or without ST elevation) * Patients must have acceptable renal and hepatic function within 4 weeks prior to registration as defined below: * Absolute neutrophil count ≥1,500/mm3 * Platelets ≥ 100,000/mm3 * Total bilirubin ≤ the upper limit of normal (ULN) * Calculated creatinine clearance must be \> 60 ml/min using the Cockcroft-Gault formula: (140-age)\*wt(kg)/(\[Cr\]\*72). For women the calculation should be multiplied by 0.85 * Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Patient without intercurrent illness likely to interfere with protocol therapy. * Patients must not have uncontrolled diabetes, uncontrolled infection despite antibiotics or uncontrolled hypertension within 30 days prior to registration.
Exclusion criteria
* Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results. * Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. * Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 30 days of first administration of study treatment (subjects with prior radiation, cytotoxic or investigational products \< 4 weeks prior to treatment might be eligible after discussion between investigator and sponsor, if toxicities from the prior treatment have been resolved to Grade 1 (NCI CTCAE version 4). * Known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Subjects who test positive for HCV antibody but negative for HCV ribonucleic acid are permitted to enroll. * Known history of testing positive for human immunodeficiency virus (HIV) and CD4 count \< 200 or known acquired immunodeficiency syndrome (AIDS). * Any Grade 4 laboratory abnormalities. * History of allergy to study drug components. * History of severe hypersensitivity reaction to any human monoclonal antibody. * Prisoners or subjects who are involuntarily incarcerated. * Subjects compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year Progression-free Survival (PFS) | At 1 year post start of treatment | The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| PEG Tube Dependence | At 1-year post-surgery | Presence /absence of enteral feeding tube. |
| Two-year Progression-free Survival (PFS) | At 2 years post start of treatment | The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MD Anderson Dysphagia Inventory (MDADI) | At baseline | The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function. |
| Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | Calculated at 30 months after start of treatment | Total scores as mean average of the combined timepoint values for the FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life. |
| MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | At baseline | MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function. |
| MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total) | Calculated at 30 months after start of treatment | Total scores as mean average of the combined timepoint values. Includes all time-points for MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in mouth and difficulty swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale).Total scores range 0-280;higher scores mean better life quality. |
| EuroQoL-5D Questionnaire | At baseline | EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state. |
| EuroQoL-5D Questionnaire (Total) | Calculated at 30 months after start of treatment | Total scores as mean average of the combined timepoint values for the EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state. |
| Worst Grade of Adverse Events Related to Treatment | Up to 24 months | Number of patients experiencing Adverse Events and Serious Adverse Events (SAE) related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |
| Modified Barium Swallow (MBS) Rating | At 6 and 24 months after completion of treatment | Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, \< 50%, \> 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point. |
| Local Recurrence-free Survival (RFS) at One Year | At 1-year post-surgery | Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| Local Recurrence-free Survival (RFS) at Two Years | At 2-years post-surgery | Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| Regional Recurrence-free Survival (RFS) | At one year post surgery | Probability of patients with disease growth that is not present within the anatomical region in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| Distant Recurrence-free Survival (RFS) at One Year | At one year post-surgery | Probability of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| Distant Recurrence-free Survival (RFS) | At 2 years post-surgery | Percentage of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. |
| Overall Survival (OS) at One Year | At one year | The probability of survival from the start of treatment. |
| Overall Survival (OS) at Two Years | At two years | The probability of survival from the start of treatment. |
| Performance Status Scale (PSS-HN) | At 3, 6, 12 and 24 months after completion of treatment | The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance. |
| MD Anderson Dysphagia Inventory (MDADI) (Total - Overall Score) | Up to 30 months after start of treatment | Total scores including all time-points for the MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function. Scores taken at month 3, 6, 12, 24 and 30 months after completion of treatment were averaged for the population and reported below. |
| Voice Handicap Index-10 (VHI-10) | At baseline | The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap. |
| Voice Handicap Index-10 (VHI-10) (Total) | Calculated at 30 months after completion of treatment | Total scores are a mean average of time-points for the VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap. |
| Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | At baseline (prior to treatment) | The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life. Total scores as mean average of the combined participant values. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determination of Oral Human Papillomavirus (HPV) DNA | At baseline prior to treatment | Determination of oral HPV DNA present/measured in oral tissue samples. |
| Presence of Plasma Cytokines | At baseline prior to treatment; Up to 5 years | Determination of cytokines present in plasma samples. The presence of cytokines in tissues can associated positively or negatively in the development of disease. |
| Tumor TP53 Mutation | At baseline prior to treatment; Up to 5 years | Determination of tumor TP53 mutation as measured in serum and/or tissue samples. The presence of TP53 mutations results in a protein that is less able to control cell proliferation as it is unable to trigger apoptosis in cells with damaged DNA. |
| Determination of Tumor Genomics | At baseline prior to treatment; Up to 5 years | Determination of tumor genomics, measured in serum and/or tissue samples. This measure will explore the of DNA sequence and gene expression differences in tumor cells and gene abnormalities may that drive the drives disease growth. |
| Antigen-specific Immune Response to Human Papillomavirus (HPV) | At baseline prior to treatment; Up to 5 years | Determination of antigen-specific cellular immune response to Human papillomavirus (HPV) measured in serum and/or tissue samples. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiotherapy (RT) + Nivolumab Injection RT of 45 or 50 Gy in 25 daily fractions, 6 fractions per week. Nivolumab will be administered at 240 mg every 2 weeks during radiotherapy, and at 480 mg every 4 weeks for 6 doses after radiotherapy.
Nivolumab Injection: A fully human anti-programmed death 1 (PD-1) monoclonal antibody
Radiotherapy (RT): 45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Radiotherapy (RT) + Nivolumab Injection |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 40 |
| other Total, other adverse events | 40 / 40 |
| serious Total, serious adverse events | 4 / 40 |
Outcome results
Primary
One-year Progression-free Survival (PFS)
The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At 1 year post start of treatment
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | One-year Progression-free Survival (PFS) | 97.50 percentage of participants |
Primary
PEG Tube Dependence
Presence /absence of enteral feeding tube.
Time frame: At 1-year post-surgery
Population: All trial participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | PEG Tube Dependence | PEG tube dependence patients | 1 Participants |
| Radiotherapy (RT) + Nivolumab Injection | PEG Tube Dependence | Patients not PEG tube dependent | 39 Participants |
Primary
Two-year Progression-free Survival (PFS)
The probability of PFS measured from of beginning of study treatment, without local, regional or distant disease recurrence (appearance of new metastatic lesions). Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At 2 years post start of treatment
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Two-year Progression-free Survival (PFS) | 90.00 percentage of participants |
Secondary
Distant Recurrence-free Survival (RFS)
Percentage of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At 2 years post-surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Distant Recurrence-free Survival (RFS) | 92.50 percentage of patients |
Secondary
Distant Recurrence-free Survival (RFS) at One Year
Probability of patients with disease that has spread (metastasized) to areas farther away from where disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At one year post-surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Distant Recurrence-free Survival (RFS) at One Year | 97.50 percentage of patients |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 9 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s) at the 9-month timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .00 score on a scale | Standard Deviation 0 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .50 score on a scale | Standard Deviation 0.707 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | 1.00 score on a scale | Standard Deviation 1.414 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | 1.00 score on a scale | Standard Deviation 1.414 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .50 score on a scale | Standard Deviation 0.707 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 62.500 score on a scale | Standard Deviation 45.9619 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At baseline
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .10 score on a scale | Standard Deviation 0.3 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .34 score on a scale | Standard Deviation 0.53 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .80 score on a scale | Standard Deviation 0.511 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .39 score on a scale | Standard Deviation 0.586 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 66.450 score on a scale | Standard Deviation 30.116 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .05 score on a scale | Standard Deviation 0.218 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 30 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 85.000 score on a scale |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 24 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .13 score on a scale | Standard Deviation 0.344 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .18 score on a scale | Standard Deviation 0.501 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .30 score on a scale | Standard Deviation 0.559 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .43 score on a scale | Standard Deviation 0.662 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .26 score on a scale | Standard Deviation 0.449 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 73.891 score on a scale | Standard Deviation 25.4058 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 12 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .10 score on a scale | Standard Deviation 0.292 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .14 score on a scale | Standard Deviation 0.43 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .30 score on a scale | Standard Deviation 0.571 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .51 score on a scale | Standard Deviation 0.612 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .16 score on a scale | Standard Deviation 0.359 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 75.348 score on a scale | Standard Deviation 27.3823 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 21 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | 1.00 score on a scale | Standard Deviation 1.414 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | 1.00 score on a scale | Standard Deviation 1.414 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .50 score on a scale | Standard Deviation 0.707 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 55.000 score on a scale | Standard Deviation 21.2132 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 18 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .00 score on a scale | Standard Deviation 0 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .25 score on a scale | Standard Deviation 0.5 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .50 score on a scale | Standard Deviation 1 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .50 score on a scale | Standard Deviation 1 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .25 score on a scale | Standard Deviation 0.5 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 75.000 score on a scale | Standard Deviation 17.3205 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 3 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s) for 3-month timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .29 score on a scale | Standard Deviation 0.488 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .00 score on a scale | Standard Deviation 0 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .43 score on a scale | Standard Deviation 0.535 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .43 score on a scale | Standard Deviation 0.787 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .29 score on a scale | Standard Deviation 0.488 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 77.857 score on a scale | Standard Deviation 13.496 |
Secondary
EuroQoL-5D Questionnaire
EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: At 6 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s) at the 6-month timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | mobility | .03 score on a scale | Standard Deviation 0.183 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | self_care | .03 score on a scale | Standard Deviation 0.18 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | usual_activities | .16 score on a scale | Standard Deviation 0.374 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | pain_discomfort | .39 score on a scale | Standard Deviation 0.495 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | anxiety_depression | .10 score on a scale | Standard Deviation 0.301 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire | Analog Scale Score | 75.017 score on a scale | Standard Deviation 28.8526 |
Secondary
EuroQoL-5D Questionnaire (Total)
Total scores as mean average of the combined timepoint values for the EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A value set consists of weights that can convert each EQ-5D health profile into a value on a scale anchored at 1 (meaning full health) and 0 (meaning a state as bad as being dead). The scale allows negative values to be assigned to health states that are considered worse than dead. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state; EQ VAS scores range from 0 to 100, where 100 is the best possible health state.
Time frame: Calculated at 30 months after start of treatment
Population: All treated patients that completed the EQ-5D questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | mobility | .08 score on a scale | Standard Deviation 0.269 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | self_care | .11 score on a scale | Standard Deviation 0.357 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | usual_activities | .31 score on a scale | Standard Deviation 0.558 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | pain_discomfort | .55 score on a scale | Standard Deviation 0.611 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | anxiety_depression | .25 score on a scale | Standard Deviation 0.478 |
| Radiotherapy (RT) + Nivolumab Injection | EuroQoL-5D Questionnaire (Total) | Analog Scale Score | 72.250 score on a scale | Standard Deviation 27.3426 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 18 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 12.5000 score on a scale | Standard Deviation 9.11043 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 20.0825 score on a scale | Standard Deviation 5.39882 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 13.7500 score on a scale | Standard Deviation 2.75379 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 21.1250 score on a scale | Standard Deviation 8.3504 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 30.5000 score on a scale | Standard Deviation 9.60902 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 106.9575 score on a scale | Standard Deviation 31.03037 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 73.1250 score on a scale | Standard Deviation 26.28807 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 76.4575 score on a scale | Standard Deviation 22.13144 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 30 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 25.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 27.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 15.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 23.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 32.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 122.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 80.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 90.0000 score on a scale |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 24 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 23.5725 score on a scale | Standard Deviation 6.0245 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 22.3332 score on a scale | Standard Deviation 5.24231 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 14.9565 score on a scale | Standard Deviation 2.34479 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 22.3043 score on a scale | Standard Deviation 6.65674 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 28.7317 score on a scale | Standard Deviation 7.34582 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 112.4083 score on a scale | Standard Deviation 22.63526 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 75.1186 score on a scale | Standard Deviation 12.41533 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 83.1666 score on a scale | Standard Deviation 16.99082 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 21 months after completion of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 56.5000 score on a scale | Standard Deviation 28.99138 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 15.5000 score on a scale | Standard Deviation 13.43503 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 15.5000 score on a scale | Standard Deviation 4.94975 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 12.0000 score on a scale | Standard Deviation 5.65685 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 15.0000 score on a scale | Standard Deviation 11.31371 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 26.0000 score on a scale | Standard Deviation 4.24264 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 84.0000 score on a scale | Standard Deviation 39.59798 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 58.0000 score on a scale | Standard Deviation 35.35534 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life. Total scores as mean average of the combined participant values.
Time frame: At baseline (prior to treatment)
Population: All treated patients that completed the FACT-HN questionnaire(s) at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 22.5275 score on a scale | Standard Deviation 5.53886 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 25.0687 score on a scale | Standard Deviation 3.18941 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 14.5282 score on a scale | Standard Deviation 1.92408 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 19.8462 score on a scale | Standard Deviation 5.46539 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 26.5156 score on a scale | Standard Deviation 7.73295 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN Total Score | 108.9554 score on a scale | Standard Deviation 17.67586 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 69.2161 score on a scale | Standard Deviation 16.77417 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 82.1589 score on a scale | Standard Deviation 10.98443 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 3 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 22.2857 score on a scale | Standard Deviation 4.64451 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 23.4524 score on a scale | Standard Deviation 5.08693 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 14.7143 score on a scale | Standard Deviation 1.38013 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 19.5714 score on a scale | Standard Deviation 7.56448 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 24.8571 score on a scale | Standard Deviation 8.23465 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 104.8810 score on a scale | Standard Deviation 24.60323 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 66.7143 score on a scale | Standard Deviation 19.49969 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 80.0239 score on a scale | Standard Deviation 17.1546 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 6 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 24.3438 score on a scale | Standard Deviation 2.61027 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 25.3800 score on a scale | Standard Deviation 3.08092 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 15.1562 score on a scale | Standard Deviation 1.68694 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 22.3906 score on a scale | Standard Deviation 5.03013 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 27.4478 score on a scale | Standard Deviation 6.01893 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 114.7184 score on a scale | Standard Deviation 14.36375 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 74.1822 score on a scale | Standard Deviation 11.97082 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 87.2706 score on a scale | Standard Deviation 9.80596 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 9 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | 17.0000 score on a scale | Standard Deviation 11.31371 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score
The FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: At 12 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | PWB | 24.1857 score on a scale | Standard Deviation 4.5408 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | SWB | 25.3809 score on a scale | Standard Deviation 3.77407 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | EWB | 14.5294 score on a scale | Standard Deviation 1.7492 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FWB | 22.5687 score on a scale | Standard Deviation 5.73219 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | HNCS | 29.8000 score on a scale | Standard Deviation 6.09146 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN | 116.2990 score on a scale | Standard Deviation 17.6276 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT HN TOI | 76.4364 score on a scale | Standard Deviation 14.81122 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score | FACT_G | 86.6226 score on a scale | Standard Deviation 12.68824 |
Secondary
Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total)
Total scores as mean average of the combined timepoint values for the FACT-H&N (version 4)17 consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. The FACT-G contains 4 subscales: physical, social/family, emotional, and functional well-being. Individuals are asked to indicate how true the statements are for them for the past 7 days. Subscale responses range from not at all (0), to very much (4) on a 5-point scale. Total scores range from 0 to 108, with higher scores indicating better quality of life.
Time frame: Calculated at 30 months after start of treatment
Population: All treated patients that completed the FACT-H\&N questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | PWB | 23.3432 score on a scale | Standard Deviation 5.17244 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | SWB | 24.5010 score on a scale | Standard Deviation 4.10237 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | EWB | 14.6476 score on a scale | Standard Deviation 2.10983 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | FWB | 21.4080 score on a scale | Standard Deviation 5.94202 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | HNCS | 27.9586 score on a scale | Standard Deviation 6.94262 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | FACT HN | 112.0201 score on a scale | Standard Deviation 19.20657 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | FACT HN TOI | 72.8599 score on a scale | Standard Deviation 16.10666 |
| Radiotherapy (RT) + Nivolumab Injection | Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Score (Total) | FACT_G | 83.9290 score on a scale | Standard Deviation 13.77629 |
Secondary
Local Recurrence-free Survival (RFS) at One Year
Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At 1-year post-surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Local Recurrence-free Survival (RFS) at One Year | 100.00 percentage of participants |
Secondary
Local Recurrence-free Survival (RFS) at Two Years
Probability of patients with disease growth that is not present within the area in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At 2-years post-surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Local Recurrence-free Survival (RFS) at Two Years | 97.50 percentage of participants |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 18 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 4.50 score on a scale | Standard Deviation 0.577 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 79.8688 score on a scale | Standard Deviation 16.88788 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 21 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 3.00 score on a scale | Standard Deviation 1.414 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 61.2871 score on a scale | Standard Deviation 17.53215 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 24 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 3.71 score on a scale | Standard Deviation 1.233 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 74.1703 score on a scale | Standard Deviation 13.44307 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 30 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 4.00 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 76.8421 score on a scale |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 6 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 3.80 score on a scale | Standard Deviation 1.186 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 72.8767 score on a scale | Standard Deviation 13.07152 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At baseline
Population: All treated patients that completed the MDADI questionnaire(s) at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily Activity (one-item Global Score summary) | 3.36 score on a scale | Standard Deviation 1.405 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 74.0217 score on a scale | Standard Deviation 11.1612 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 12 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 3.91 score on a scale | Standard Deviation 1.04 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 76.0519 score on a scale | Standard Deviation 12.039 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 3 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 3.67 score on a scale | Standard Deviation 1.366 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 67.2227 score on a scale | Standard Deviation 9.60136 |
Secondary
MD Anderson Dysphagia Inventory (MDADI)
The MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function.
Time frame: At 9 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Daily (one-item Global Score summary) | 4.00 score on a scale | Standard Deviation 0 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) | Composite (average across 19 items) | 74.2105 score on a scale | Standard Deviation 6.69891 |
Secondary
MD Anderson Dysphagia Inventory (MDADI) (Total - Overall Score)
Total scores including all time-points for the MDADI measures swallowing-related quality of life (QOL) in patients with swallowing dysfunction in a 20 - item written questionnaire. Each item is scored on a 5-point Likert scale (scoring is 5-strongly disagree, 4-disagree, 3-no opinion, 2-agree, 1-strongly agree). Subscales evaluate the patient's physical (P), emotional (E) and functional (F) perceptions of swallowing dysfunction. A composite score is generated by calculating the mean response for the 19 items (excluding the global question) making up the emotional, functional and physical subscales and multiplying the result by 20, resulting in a score ranging from 20 representing a low QOL function to 100 indicating high QOL. Higher scores indicate better perception of swallowing function. Scores taken at month 3, 6, 12, 24 and 30 months after completion of treatment were averaged for the population and reported below.
Time frame: Up to 30 months after start of treatment
Population: All treated patients that completed the MDADI questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) (Total - Overall Score) | Daily (one-item Global Score summary) | 3.70 score on a scale | Standard Deviation 1.216 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Dysphagia Inventory (MDADI) (Total - Overall Score) | Composite (average across 19 items) | 74.0179 score on a scale | Standard Deviation 12.27447 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN measures treatment related symptom burden in head and neck cancer patients. The 20-item MDASI measures both severity and burden of symptoms and their effect on patients' daily activities, using a numeric rating scale of 0-10. This instrument includes 13 core symptoms and 9 head and neck specific items. Higher scores indicate superior perception of function.
Time frame: At baseline
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 2.4158 score on a scale | Standard Deviation 2.20166 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 1.6094 score on a scale | Standard Deviation 1.28258 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | 1.2133 score on a scale | Standard Deviation 1.55947 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 3 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 2.6272 score on a scale | Standard Deviation 1.8146 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 3.6945 score on a scale | Standard Deviation 1.91017 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | 1.1852 score on a scale | Standard Deviation 1.61882 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 6 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 1.4928 score on a scale | Standard Deviation 0.9653 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 2.9615 score on a scale | Standard Deviation 1.87749 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | .6076 score on a scale | Standard Deviation 0.73105 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 9 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 5.1538 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 5.8333 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | 3.8889 score on a scale |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 12 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 1.7163 score on a scale | Standard Deviation 1.40834 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 2.5912 score on a scale | Standard Deviation 1.87383 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | .8239 score on a scale | Standard Deviation 1.30055 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 18 months
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 2.4615 score on a scale | Standard Deviation 2.8648 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 3.2222 score on a scale | Standard Deviation 2.00924 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | 1.2222 score on a scale | Standard Deviation 1.92771 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 21 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 3.2692 score on a scale | Standard Deviation 2.66525 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 3.3333 score on a scale | Standard Deviation 1.41421 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | 1.8333 score on a scale | Standard Deviation 2.59272 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 24 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 1.8379 score on a scale | Standard Deviation 1.95695 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 2.9444 score on a scale | Standard Deviation 2.52938 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | .9027 score on a scale | Standard Deviation 1.61271 |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN)
MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in the mouth and difficulty in swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (ie, 7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale). Total scores range from 0 to 280, with higher scores indicating better quality of life/lesser impairment.
Time frame: At 30 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Core mean | 1.2308 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | Interference mean | 1.0000 score on a scale |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) | HN symptoms mean | .3333 score on a scale |
Secondary
MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total)
Total scores as mean average of the combined timepoint values. Includes all time-points for MDASI-HN is a 28 symptom items questionnaire of 13 general cancer-related symptoms, such as pain, fatigue and nausea; 9 HNC-related symptoms, such as problems with mucus in mouth and difficulty swallowing or chewing; 6 items to evaluate the effects of symptoms on daily life, including mood and enjoyment of life. Each item/subscale is rated on a 11-point scale from 0 (not at all) to 10 (as bad as you can imagine), while the items that assess the interference of symptoms on daily activities are rated from 0 (does not interfere) to 10 (interfered completely). When calculating any subscale score (arithmetic mean of items in the subscale), a majority of the subscale's items must have been responded to (7 of the 13 core symptom severity items or 4 of the 6 interference items would represent the majority of the items for the subscale).Total scores range 0-280;higher scores mean better life quality.
Time frame: Calculated at 30 months after start of treatment
Population: All treated patients that completed the MDASI-HN questionnaire(s).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total) | Core mean | 1.7527 score on a scale | Standard Deviation 1.48249 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total) | Interference mean | 2.7670 score on a scale | Standard Deviation 2.08132 |
| Radiotherapy (RT) + Nivolumab Injection | MD Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN) (Total) | HN symptoms mean | .9527 score on a scale | Standard Deviation 1.38315 |
Secondary
Modified Barium Swallow (MBS) Rating
Three swallowing outcomes will be rated by the SLP conducting the MBS study and reported by research staff: 1) laryngeal penetration (yes, no); 2) aspiration (no, sensate, silent), and 3) pharyngeal residue (no, \< 50%, \> 50%). These have been selected as universal items generally reported by swallowing clinicians that have been shown to significantly predict pneumonia in patients with oropharyngeal cancers. Prevalence of these dysphagia endpoints will be estimated at each time point.
Time frame: At 6 and 24 months after completion of treatment
Population: Data were not collected.
Secondary
Overall Survival (OS) at One Year
The probability of survival from the start of treatment.
Time frame: At one year
Population: All trial participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Overall Survival (OS) at One Year | 100.00 percentage of participants |
Secondary
Overall Survival (OS) at Two Years
The probability of survival from the start of treatment.
Time frame: At two years
Population: All trial participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Overall Survival (OS) at Two Years | 97.50 percentage of participants |
Secondary
Performance Status Scale (PSS-HN)
The Performance Status Scale (PSS-HN) is a clinician-rated instrument consisting of 3 questions: normalcy of diet, public eating/swallowing, and understandability of speech subscales in patients with head and neck cancer. Each subscale is rated from 0 to 100, with higher scores indicating better performance.
Time frame: At 3, 6, 12 and 24 months after completion of treatment
Population: Data were not collected.
Secondary
Regional Recurrence-free Survival (RFS)
Probability of patients with disease growth that is not present within the anatomical region in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At two years post-surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Regional Recurrence-free Survival (RFS) | 100.00 participants |
Secondary
Regional Recurrence-free Survival (RFS)
Probability of patients with disease growth that is not present within the anatomical region in which disease was first located. Measurement/determination of disease progression (recurrence) by CT and MRI, Chest X-Ray (Lesions acceptable as measurable when clearly defined and surrounded by an aerated lung), Tumor Markers, Clinical Examination (Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For skin lesions, documentation by color photography, including a ruler to estimate size of the lesion, Cytology and Histology (Cytologic confirmation of the neoplastic nature of any effusion that appears or worsens during treatment is required when the measurable tumor has met response or stable disease criteria, Ultrasound (Ultrasound may be used only as an alternative to clinical measurements for superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules.
Time frame: At one year post surgery
Population: All patients treated with Radiotherapy (RT) and Nivolumab with radiologic evaluation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Regional Recurrence-free Survival (RFS) | 100.00 percentage of participants |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At baseline
Population: All treated patients that completed the VHI-10 questionnaire(s) at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 7.2432 score on a scale | Standard Deviation 8.01875 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 30 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 30-month timepoint.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 0.0000 score on a scale |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 18 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 18-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 6.0000 score on a scale | Standard Deviation 6.08276 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 21 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 21-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 6.0000 score on a scale | Standard Deviation 1.41421 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 12 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 12-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 4.5714 score on a scale | Standard Deviation 5.82609 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 9 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 9-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 6.0000 score on a scale | Standard Deviation 5.65685 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 6 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 6-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 3.7000 score on a scale | Standard Deviation 4.74269 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 3 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 3-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 3.8333 score on a scale | Standard Deviation 4.75044 |
Secondary
Voice Handicap Index-10 (VHI-10)
The VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: At 24 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s) for 24-month timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) | 4.1667 score on a scale | Standard Deviation 5.8508 |
Secondary
Voice Handicap Index-10 (VHI-10) (Total)
Total scores are a mean average of time-points for the VHI-10 is a patient self-assessment instrument that quantifies patients' perception of their voice handicap. It evaluates patient's physical (P), emotional (E), and functional (F) perceptions of voice and has shown to be highly reliable for internal consistency and test-retest stability. The VHI-10 utilizes a 10-item questionnaire in which the patient circles the response that most accurately reflects his or her own experience on a linear scale (from never to always). Always response is scored 4 points, a Never response is scored 0. The remaining options are scored between 1 and 3 points. The tallied number of points for each of the subscales is computed to a total composite score. Scores for the VHI-10 range from zero-to-40, with higher scores indicating a greater voice-related handicap.
Time frame: Calculated at 30 months after completion of treatment
Population: All treated patients that completed the VHI-10 questionnaire(s).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Voice Handicap Index-10 (VHI-10) (Total) | 5.0286 score on a scale | Standard Deviation 6.24983 |
Secondary
Worst Grade of Adverse Events Related to Treatment
Number of patients experiencing Adverse Events and Serious Adverse Events (SAE) related to study treatment per Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Up to 24 months
Population: All patients treated with Radiotherapy (RT) and Nivolumab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Radiotherapy (RT) + Nivolumab Injection | Worst Grade of Adverse Events Related to Treatment | Grade 2 | 9 participants |
| Radiotherapy (RT) + Nivolumab Injection | Worst Grade of Adverse Events Related to Treatment | Grade 3 | 29 participants |
| Radiotherapy (RT) + Nivolumab Injection | Worst Grade of Adverse Events Related to Treatment | Grade 4 | 2 participants |
Other Pre-specified
Antigen-specific Immune Response to Human Papillomavirus (HPV)
Determination of antigen-specific cellular immune response to Human papillomavirus (HPV) measured in serum and/or tissue samples.
Time frame: At baseline prior to treatment; Up to 5 years
Other Pre-specified
Determination of Oral Human Papillomavirus (HPV) DNA
Determination of oral HPV DNA present/measured in oral tissue samples.
Time frame: At baseline prior to treatment
Other Pre-specified
Determination of Tumor Genomics
Determination of tumor genomics, measured in serum and/or tissue samples. This measure will explore the of DNA sequence and gene expression differences in tumor cells and gene abnormalities may that drive the drives disease growth.
Time frame: At baseline prior to treatment; Up to 5 years
Other Pre-specified
Presence of Plasma Cytokines
Determination of cytokines present in plasma samples. The presence of cytokines in tissues can associated positively or negatively in the development of disease.
Time frame: At baseline prior to treatment; Up to 5 years
Other Pre-specified
Tumor TP53 Mutation
Determination of tumor TP53 mutation as measured in serum and/or tissue samples. The presence of TP53 mutations results in a protein that is less able to control cell proliferation as it is unable to trigger apoptosis in cells with damaged DNA.
Time frame: At baseline prior to treatment; Up to 5 years