Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Conditions
Keywords
Human Papilloma Virus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy, p16
Brief summary
The purpose of this research study is to learn about the effectiveness of using lower-intensity radiation and chemotherapy to treat human papillomavirus (HPV) associated low-risk oropharyngeal and/or unknown primary squamous cell carcinomas of the head and neck. The cure rate for this type of cancer is estimated to be high, \> 90%. The standard treatment for this cancer is 7 weeks of radiation with 3 high doses of cisplatin. Sometimes surgery is performed afterwards. This standard regimen causes a lot of side effects and long term complications. This study is evaluating whether a lower dose of radiation and chemotherapy may provide a similar cure rate as the longer, more intensive standard regimen. Patients in this study will receive 1 less week of radiation and a lower weekly dose of chemotherapy followed by a limited surgical evaluation.
Detailed description
The aim is to evaluate the pathological response rate of HPV positive and/or p16 positive low-risk oropharyngeal squamous cell carcinoma (OPSCC) after de-intensified chemoradiotherapy (CRT). Patients will receive 54 to 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) will be obtained 4 to 8 weeks after completion of CRT to assess response. All patients will have surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there is no evidence of residual tumor and will undergo a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT. The primary endpoint of this study is the rate of pathological complete response (pCR) after CRT. Longitudinal assessments of quality of life and patient reported outcomes will be obtained prior to, during, and after CRT.
Interventions
All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease).
DRUGCisplatin
Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory.
PROCEDURELimited surgical evaluation
4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT.
Sponsors
UNC Lineberger Comprehensive Cancer Center
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
1. ≥ 18 years of age 2. T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx 3. Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive 4. ≤ 10 pack-years smoking history or \> 5 years of abstinence from smoking 5. History/physical examination within 8 weeks prior to registration 6. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to registration. 7. The Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 8. Complete Blood Count (CBC)/differential obtained within 4 weeks prior to registration, with adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl. 9. Adequate renal and hepatic function within 4 weeks prior to registration, defined as follows: Serum creatinine \< 2.0 mg/dl; Total bilirubin \< 2 x the institutional upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 x the institutional ULN. 10. Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential. 11. Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment. 12. Patients must be deemed able to comply with the treatment plan and follow-up schedule. 13. Patients must provide study specific informed consent prior to study entry.
Exclusion criteria
1. Prior history of radiation therapy to the head and neck 2. Prior history of head and neck cancer. 3. Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol; Pre-existing ≥ grade 2 neuropathy; Prior organ transplant. 4. Known HIV positive 5. Significant pre-existing hearing loss, as defined by the patient or treating physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). | 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened | Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two-Year Local Control | Median follow-up was 36 months with a range of 5-53 months | Local control is the arrest of cancer growth at the site of origin. |
| Regional Control | Median follow-up was 36 months with a range of 5-53 months | Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin. |
| Cause-Specific Survival | The median follow-up was 36 months with a range of 5-53 months | Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC. |
| Distant Metastases Free Survival | the median follow-up was 36 months with a range of | Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread. |
| Overall Survival Rate | Median follow-up was 36 months with a range of 5-53 months. | The percentage of participants who are still alive from the start of treatment. |
| European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT | The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms. |
| The Eating Assessment Tool (EAT-10) Composite Score | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT | The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40. |
| The Rosenbek Penetration Aspiration Scale | Prior to CRT and 4-8 weeks after completion of CRT | The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1\. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject. |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT | The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). |
Countries
United States
Participant flow
Recruitment details
Enrolling institutions included University of North Carolina Hospitals (Chapel Hill, NC), University of Florida Hospitals (Gainesville, FL), and Rex Hospital (Raleigh, NC).
Pre-assignment details
Sixty-nine patients were eligible for enrollment, of whom 45 were accrued. One patient had a cerebrovascular accident during de-intensified CRT and was taken off the study. After the completion of CRT, 1 patient refused the planned surgical evaluation, leaving 43 patients who were fully evaluable.
Participants by arm
| Arm | Count |
|---|---|
| De-escalated Radiation and Chemotherapy Patients received 60 Gy of Intensity Modulated Radiotherapy (IMRT) with concurrent weekly intravenous cisplatin (30 mg/m2). Diagnostic imaging (CT and/or MRI) was obtained 4 to 8 weeks after completion of CRT to assess response. Patients received surgical resection of any clinically apparent residual primary tumor or biopsy of the primary site if there was no evidence of residual tumor and underwent a limited neck dissection to encompass at least those nodal level(s) that were positive pre-treatment, 4 to 14 weeks after CRT.
Intensity Modulated Radiotherapy (IMRT): All patients received IMRT. Dose painting IMRT was used and all doses were specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) was treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR was 2 Gy/day and 1.8 Gy/day, respectively. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | De-escalated Radiation and Chemotherapy |
|---|---|
| Age, Continuous | 61 years |
| HPV/p16 Status HPV-/p16+ | 16 Participants |
| HPV/p16 Status HPV+/p16+ | 28 Participants |
| Marital Status Married | 34 Participants |
| Marital Status Unmarried | 10 Participants |
| N Stage N0 | 4 Participants |
| N Stage N1 | 10 Participants |
| N Stage N2a | 2 Participants |
| N Stage N2b | 21 Participants |
| N Stage N2c | 7 Participants |
| Primary Tumor Location Base of Tongue | 26 Participants |
| Primary Tumor Location Tonsil | 16 Participants |
| Primary Tumor Location Unknown Primary | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 5 Participants |
| Tobacco Use <=10 Pack Years | 6 Participants |
| Tobacco Use > 10 Pack Years | 2 Participants |
| Tobacco Use Never Smoker | 36 Participants |
| T Stage T0 | 2 Participants |
| T Stage T1 | 13 Participants |
| T Stage T2 | 22 Participants |
| T Stage T3 | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 45 |
| other Total, other adverse events | 40 / 45 |
| serious Total, serious adverse events | 15 / 45 |
Outcome results
Primary
Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC).
Pathologic Complete Response Rate is defined as no evidence of residual viable cancer in the evaluated pathological specimens.
Time frame: 6 to 14 weeks after the last patient is enrolled, or approximately 24 to 32 months after study being opened
Population: Following the completion of chemoradiation therapy (CRT), 1 patient refused the planned surgical evaluation and 43 patients were evaluated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Pathologic Complete Response Rate After De-escalated CRT in HPV-positive and/or p16 Positive Oropharyngeal Squamous Cell Carcinoma (OPSCC). | 37 Participants |
Secondary
Cause-Specific Survival
Cause-specific survival is the percentage of participants who have not died from low-risk low-risk OPSCC.
Time frame: The median follow-up was 36 months with a range of 5-53 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Cause-Specific Survival | 100 percentage of participants |
Secondary
Distant Metastases Free Survival
Distant metastases free survival is the percentage of subjects in a study who have survived without cancer spread.
Time frame: the median follow-up was 36 months with a range of
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Distant Metastases Free Survival | 100 percentage of participants |
Secondary
European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL
The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions which incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.
Time frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Social functioning | 88 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Role functioning | 96 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Insomnia | 23 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Fatigue | 20 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Physical functioning | 96 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Dyspnea | 5 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Nausea and vomiting | 2 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Constipation | 12 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Pain | 15 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Emotional functioning | 77 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Financial difficulties | 16 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Global health status/QoL | 80 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Cognitive functioning | 91 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Diarrhea | 5 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Appetite loss | 14 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Appetite loss | 40 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Global health status/QoL | 61 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Physical functioning | 78 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Role functioning | 65 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Emotional functioning | 77 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Cognitive functioning | 86 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Social functioning | 66 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Fatigue | 42 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Nausea and vomiting | 13 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Pain | 21 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Dyspnea | 11 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Insomnia | 34 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Constipation | 17 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Diarrhea | 4 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Financial difficulties | 28 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Social functioning | 81 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Diarrhea | 6 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Insomnia | 23 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Cognitive functioning | 87 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Emotional functioning | 84 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Appetite loss | 33 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Role functioning | 77 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Global health status/QoL | 69 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Constipation | 16 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Nausea and vomiting | 4 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Physical functioning | 85 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Pain | 20 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Fatigue | 31 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Financial difficulties | 22 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status/QoL | Dyspnea | 6 units on a scale |
Secondary
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35
The head & neck cancer module of the EORTC QLQ comprises 35 questions assessing symptoms and side effects of treatment, social function and body image/sexuality. The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); several single item questions (Pain killers, nutritional supplements, feeding tube, weight loss, and weight gain) were just coded as no=1, yes=2. The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning).
Time frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Eating | 8 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Contact | 5 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Less Sexuality | 13 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Nutritional Supplements | 39 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Teeth | 3 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Opening Mouth | 5 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Feeding Tube | 0 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Dry Mouth | 16 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Senses Problems | 5 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Loss | 20 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Cough | 17 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Gain | 25 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain | 19 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Sticky Saliva | 6 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Swallowing | 11 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Felt Ill | 8 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Speech Problems | 10 units on a scale |
| De-escalated Radiation and Chemotherapy | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain Killers | 34 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Feeding Tube | 40 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Eating | 29 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain Killers | 43 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Senses Problems | 35 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Contact | 15 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Sticky Saliva | 61 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Loss | 38 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Less Sexuality | 34 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Felt Ill | 20 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Swallowing | 19 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Teeth | 10 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Nutritional Supplements | 55 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Gain | 40 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Opening Mouth | 15 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Cough | 25 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Speech Problems | 13 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Dry Mouth | 69 units on a scale |
| 6-8 Weeks Post-Treatment | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain | 25 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Dry Mouth | 64 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Felt Ill | 11 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Feeding Tube | 17 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Sticky Saliva | 49 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Cough | 22 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain Killers | 33 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Nutritional Supplements | 40 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Loss | 36 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Weight Gain | 10 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Pain | 26 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Swallowing | 18 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Senses Problems | 28 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Speech Problems | 16 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Eating | 24 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Trouble with Social Contact | 8 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Less Sexuality | 23 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Teeth | 12 units on a scale |
| Post-Surgery | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N-35 | Opening Mouth | 18 units on a scale |
Secondary
Overall Survival Rate
The percentage of participants who are still alive from the start of treatment.
Time frame: Median follow-up was 36 months with a range of 5-53 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Overall Survival Rate | 95 percentage of participants |
Secondary
Regional Control
Regional control is the percentage of participants who displayed control of cancer in sites that represent the first stages of spread from the local origin.
Time frame: Median follow-up was 36 months with a range of 5-53 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Regional Control | 100 percentage of participants |
Secondary
The Eating Assessment Tool (EAT-10) Composite Score
The EAT-10 is a 10 item, validated self-administered instrument for documenting dysphagia severity. This questionnaire uses symptom-specific scores to assess dysphasia with solids, liquids, and pills as well as the impact of dysphagia on mental, social, and physical health. Higher raw scores represent worse QoL. All items have a 0-4 scale where 0 represents no problem and 4 represents severe problem. Total score can range from 0 to 40.
Time frame: Prior to CRT, 4-8 weeks after CRT, follow-up visits for 2 years after CRT
| Arm | Measure | Value (MEAN) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | The Eating Assessment Tool (EAT-10) Composite Score | 4 units on a scale |
| 6-8 Weeks Post-Treatment | The Eating Assessment Tool (EAT-10) Composite Score | 13 units on a scale |
| Post-Surgery | The Eating Assessment Tool (EAT-10) Composite Score | 11 units on a scale |
Secondary
The Rosenbek Penetration Aspiration Scale
The Rosenbek Penetration Aspiration Scale will be used to quantify dysphagia. It is an 8-point, equal-appearing interval scale to describe penetration and aspiration events. The measure was used for thin substances, pureed substances, and solid substances. 1\. Material does not enter airway 2. Material enters the airway, remains above the vocal folds, and is ejected from the airway. 3. Material enters the airway, remains above the vocal folds, and is not ejected from the airway. 4. Material enters the airway, contacts the vocal folds, and is ejected from the airway. 5. Material enters the airway, contacts the vocal folds, and is not ejected from the airway. 6.Material enters the airway, passes below the vocal folds, and is ejected into the larynx or out of the airway. 7. Material enters the airway, passes below the vocal folds, and is not ejected from the trachea despite effort. 8. Material enters the airway, passes below the vocal folds, and no effort is made to eject.
Time frame: Prior to CRT and 4-8 weeks after completion of CRT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| De-escalated Radiation and Chemotherapy | The Rosenbek Penetration Aspiration Scale | Thin Substances | 1.30 units on a scale | Standard Deviation 0.62 |
| De-escalated Radiation and Chemotherapy | The Rosenbek Penetration Aspiration Scale | Pureed Substances | 1.03 units on a scale | Standard Deviation 0.16 |
| De-escalated Radiation and Chemotherapy | The Rosenbek Penetration Aspiration Scale | Solid Substances | 1.03 units on a scale | Standard Deviation 0.16 |
| 6-8 Weeks Post-Treatment | The Rosenbek Penetration Aspiration Scale | Thin Substances | 1.90 units on a scale | Standard Deviation 1.83 |
| 6-8 Weeks Post-Treatment | The Rosenbek Penetration Aspiration Scale | Pureed Substances | 1.19 units on a scale | Standard Deviation 0.54 |
| 6-8 Weeks Post-Treatment | The Rosenbek Penetration Aspiration Scale | Solid Substances | 1.03 units on a scale | Standard Deviation 0.19 |
Secondary
Two-Year Local Control
Local control is the arrest of cancer growth at the site of origin.
Time frame: Median follow-up was 36 months with a range of 5-53 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| De-escalated Radiation and Chemotherapy | Two-Year Local Control | 100 percentage of participants |