Carcinoma, Squamous Cell, Head and Neck Neoplasms, Oropharyngeal Neoplasms
Conditions
Keywords
Human Papillomavirus, Oropharynx, Oropharyngeal Squamous Cell Carcinoma, Squamous Cell Carcinoma, Radiation Therapy, Chemotherapy, p16
Brief summary
The primary objective of this study is to evaluate whether genomic based risk-stratification can be used in deciding whether to de-intensify in patients with Human Papillomavirus (HPV)-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) with \> 10 pack years smoking history. Hypothesis: Patients with HPV-associated OPSCC, \> 10 pack years smoking history, and non-mutated p53 will have similar 2 year progression-free survival (PFS) as patients with \< 10 pack years smoking history.
Detailed description
The proposed study is a follow-up study to LCCC 1120 and 1413. The investigators have shown that de-intensification is efficacious in these two phase II studies. A major question is whether the investigators can de-intensify in patients with HPV-associated oropharyngeal cancer who have smoking histories. The investigators' hypothesis is that genomic profiling of patients' tumors (specifically for p53 mutations) will help in triaging patients to de-intensification versus standard of care. Patients with HPV-associated OPSCC will be enrolled regardless of smoking history and p53 mutational status will be assessed in patients with a smoking history. The investigators will use the same de-intensification chemoradiotherapy regimen already evaluated in LCCC 1120 and 1413 in patients with HPV-associated OPSCC who have a minimal smoking history and in patients with a smoking history but with wild-type p53. Patients with a smoking history who have mutated p53 will not receive de-intensified chemoradiotherapy, but instead will receive standard doses. The hypothesis is that by using genomics in the patients with a significant smoking history, the investigators will better select those who can be safely de-intensified. Circulating free HPV DNA (cf-HPV-DNA) will also be prospectively assessed from blood samples.
Interventions
60- 70 Gy at 2 Gy/fx
The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 -7 total doses.
PROCEDUREAssessment for surgical evaluation
Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.
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 (no upper age limit) 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. Radiologic confirmation of the absence of hematogenous metastasis within 12 weeks prior to treatment 5. ECOG Performance Status 0-1 6. CBC/differential obtained within 8 weeks prior to treatment, with adequate bone marrow function defined as follows: Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl 7. Adequate renal and hepatic function within 4 weeks prior to treatment, defined as follows: Serum creatinine \< 2.0 mg/dl; Total bilirubin \< 2 x the institutional ULN; AST or ALT \< 3 x the institutional ULN 8. Negative pregnancy test within 2 weeks prior to treatment for women of childbearing potential 9. Women of childbearing potential and male participants who are sexually active must practice adequate contraception during treatment and for 6 weeks following treatment. 10. Patients must be deemed able to comply with the treatment plan and follow-up schedule. 11. 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. Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves) 4. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) 5. 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; Systemic lupus; Psoriatic arthritis 6. Known HIV positive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Two years after completion of the treatment | PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Plasma Circulating Free DNA -3months | 3 months after completion of the treatment | The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated. |
| Number of Participants With Plasma Circulating Free DNA -1 Year | 1 year after completion of the treatment | The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated. |
| Number of Participants With Plasma Circulating Free DNA -2 Year | 2 years after completion of the treatment | The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated. |
| Local Control Rate | 2 years after completion of the treatment | The local control rate is defined as the total disappearance of the primary tumor without any local recurrence. Local recurrence was defined as biopsy-proven tumor cells in the primary tumor region. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment. |
| Number of Participants With Plasma Circulating Free DNA -Baseline | Baseline | The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated. |
| Local-regional Control Rate | 2 years after completion of the treatment | Local-regional control rate is defined as the total disappearance of the primary tumor and related lymph node metastases without any recurrence. Local-regional recurrence was defined as biopsy-proven tumor cells in the primary tumor region and/or related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment. |
| Distant Metastasis Free Survival | Two years after completion of the treatment | Distant metastasis-free survival is defined as the time from the first day of the study treatment to the date of disease spreads while subjects are alive. Distant metastasis-free survival is defined as no disease outside of the primary tumor and related lymph node metastases. Distant metastasis was defined as biopsy-proven tumor cells outside of the primary tumor and related lymph node metastases. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment. |
| Overall Survival Rate | Up to 2 years after completion of treatment | The overall survival rate is defined as the time from the first day of the study treatment to the date of death for any cause. Subjects who have not had an event will be censored at the date of the last assessment documenting the subject was alive. |
| Regional Control Rate | 2 years post-CRT | Regional control rate is defined as the total disease disappearance of the related lymph node metastases without any lymph node recurrence. Regional recurrence was defined as biopsy proven tumor cells in related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 08/25/2016 through 12/11/2020 at 4 cancer centers in the United States.
Pre-assignment details
A total of 195 subjects consented and started the study. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included and 126 subjects with arm/group and follow-up were presented.
Participants by arm
| Arm | Count |
|---|---|
| Group A Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy. | 18 |
| Group B Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy. | 105 |
| Group C Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy. | 3 |
| Group Data Unknown Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. Demographic data and site assignment for all subjects were stored centrally. Therefore, arm/group and follow-up data related to sixty-nine subjects are missing. | 69 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Research at two study sites terminated early | 0 | 0 | 0 | 69 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Group A | Total | Group Data Unknown | Group C | Group B |
|---|---|---|---|---|---|
| Age, Continuous | 62.72 years STANDARD_DEVIATION 8.43 | 60.86 years STANDARD_DEVIATION 9.61 | 64.5 years STANDARD_DEVIATION 9.74 | 61.66 years STANDARD_DEVIATION 4.16 | 59.89 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 5 Participants | 2 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 185 Participants | 67 Participants | 3 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 7 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 10 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) White | 17 Participants | 177 Participants | 67 Participants | 2 Participants | 91 Participants |
| Region of Enrollment United States | 18 participants | 195 participants | 69 participants | 3 participants | 105 participants |
| Sex: Female, Male Female | 1 Participants | 19 Participants | 3 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 17 Participants | 176 Participants | 66 Participants | 0 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 18 | 4 / 105 | 0 / 3 | 0 / 69 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Progression Free Survival (PFS)
PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up.
Time frame: Two years after completion of the treatment
Population: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Progression Free Survival (PFS) | Biopsy proven relapse was found | 3 Participants |
| Group A | Progression Free Survival (PFS) | Biopsy proven relapse was not found | 8 Participants |
| Group B | Progression Free Survival (PFS) | Biopsy proven relapse was found | 6 Participants |
| Group B | Progression Free Survival (PFS) | Biopsy proven relapse was not found | 45 Participants |
| Group C | Progression Free Survival (PFS) | Biopsy proven relapse was found | 0 Participants |
| Group C | Progression Free Survival (PFS) | Biopsy proven relapse was not found | 2 Participants |
Secondary
Distant Metastasis Free Survival
Distant metastasis-free survival is defined as the time from the first day of the study treatment to the date of disease spreads while subjects are alive. Distant metastasis-free survival is defined as no disease outside of the primary tumor and related lymph node metastases. Distant metastasis was defined as biopsy-proven tumor cells outside of the primary tumor and related lymph node metastases. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Time frame: Two years after completion of the treatment
Population: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Distant Metastasis Free Survival | Biopsy proven distant metastasis was found | 2 Participants |
| Group A | Distant Metastasis Free Survival | Biopsy proven distant metastasis was not found | 9 Participants |
| Group B | Distant Metastasis Free Survival | Biopsy proven distant metastasis was found | 4 Participants |
| Group B | Distant Metastasis Free Survival | Biopsy proven distant metastasis was not found | 47 Participants |
| Group C | Distant Metastasis Free Survival | Biopsy proven distant metastasis was found | 0 Participants |
| Group C | Distant Metastasis Free Survival | Biopsy proven distant metastasis was not found | 2 Participants |
Secondary
Local Control Rate
The local control rate is defined as the total disappearance of the primary tumor without any local recurrence. Local recurrence was defined as biopsy-proven tumor cells in the primary tumor region. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Time frame: 2 years after completion of the treatment
Population: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Local Control Rate | local relapse | 0 Participants |
| Group A | Local Control Rate | No local relapse | 11 Participants |
| Group B | Local Control Rate | local relapse | 0 Participants |
| Group B | Local Control Rate | No local relapse | 51 Participants |
| Group C | Local Control Rate | local relapse | 0 Participants |
| Group C | Local Control Rate | No local relapse | 2 Participants |
Secondary
Local-regional Control Rate
Local-regional control rate is defined as the total disappearance of the primary tumor and related lymph node metastases without any recurrence. Local-regional recurrence was defined as biopsy-proven tumor cells in the primary tumor region and/or related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Time frame: 2 years after completion of the treatment
Population: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Local-regional Control Rate | Biopsy proven local or regional relapse was found | 1 Participants |
| Group A | Local-regional Control Rate | Biopsy proven local or regional relapse was not found | 10 Participants |
| Group B | Local-regional Control Rate | Biopsy proven local or regional relapse was found | 2 Participants |
| Group B | Local-regional Control Rate | Biopsy proven local or regional relapse was not found | 49 Participants |
| Group C | Local-regional Control Rate | Biopsy proven local or regional relapse was found | 0 Participants |
| Group C | Local-regional Control Rate | Biopsy proven local or regional relapse was not found | 2 Participants |
Secondary
Number of Participants With Plasma Circulating Free DNA -1 Year
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Time frame: 1 year after completion of the treatment
Population: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis 1 year after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (+) | 2 Participants |
| Group A | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (-) | 5 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (+) | 10 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (-) | 41 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (+) | 0 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -1 Year | HPV (-) | 0 Participants |
Secondary
Number of Participants With Plasma Circulating Free DNA -2 Year
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Time frame: 2 years after completion of the treatment
Population: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis 2 years after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (+) | 2 Participants |
| Group A | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (-) | 4 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (+) | 16 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (-) | 23 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (+) | 0 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -2 Year | HPV (-) | 1 Participants |
Secondary
Number of Participants With Plasma Circulating Free DNA -3months
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Time frame: 3 months after completion of the treatment
Population: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis at 3 months after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Participants With Plasma Circulating Free DNA -3months | HPV (+) | 3 Participants |
| Group A | Number of Participants With Plasma Circulating Free DNA -3months | HPV (-) | 10 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -3months | HPV (+) | 19 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -3months | HPV (-) | 40 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -3months | HPV (+) | 0 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -3months | HPV (-) | 1 Participants |
Secondary
Number of Participants With Plasma Circulating Free DNA -Baseline
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Time frame: Baseline
Population: Subjects started the treatment and provided specimens for plasma circulating free HPV DNA analysis at baseline. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (+) | 13 Participants |
| Group A | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (-) | 1 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (+) | 59 Participants |
| Group B | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (-) | 4 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (+) | 2 Participants |
| Group C | Number of Participants With Plasma Circulating Free DNA -Baseline | HPV (-) | 0 Participants |
Secondary
Overall Survival Rate
The overall survival rate is defined as the time from the first day of the study treatment to the date of death for any cause. Subjects who have not had an event will be censored at the date of the last assessment documenting the subject was alive.
Time frame: Up to 2 years after completion of treatment
Population: Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Overall Survival Rate | Death | 1 Participants |
| Group A | Overall Survival Rate | Alive | 11 Participants |
| Group B | Overall Survival Rate | Death | 4 Participants |
| Group B | Overall Survival Rate | Alive | 51 Participants |
| Group C | Overall Survival Rate | Death | 0 Participants |
| Group C | Overall Survival Rate | Alive | 2 Participants |
Secondary
Regional Control Rate
Regional control rate is defined as the total disease disappearance of the related lymph node metastases without any lymph node recurrence. Regional recurrence was defined as biopsy proven tumor cells in related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Time frame: 2 years post-CRT
Population: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Regional Control Rate | Biopsy proven regional relapse was not found | 10 Participants |
| Group A | Regional Control Rate | Biopsy proven regional relapse was found | 1 Participants |
| Group B | Regional Control Rate | Biopsy proven regional relapse was found | 2 Participants |
| Group B | Regional Control Rate | Biopsy proven regional relapse was not found | 49 Participants |
| Group C | Regional Control Rate | Biopsy proven regional relapse was found | 0 Participants |
| Group C | Regional Control Rate | Biopsy proven regional relapse was not found | 2 Participants |