TriangleNCT03258554 · STUDY IN CONTEXT
Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
DLTs were collected to verify the safety of durvalumab with RT in this population. Safety was determined if ≤ 2 of 8 participants in the cohort had any DLT, in which case the study would proceed to phase II with that dose schedule (DS). The probability for the DS to be deemed too toxic, given a true toxicity rate ≥ 45%, is at least 78%. With a true toxicity rate ≤ 20%, the probability for the DS do be deemed safe is 80%. The full DLT definition does not fit here, but includes all grade 5 AEs, grade 3 or 4 AEs definitely or probably related to durvalumab (DPRD) except for specified AEs and situations, and incomplete or \> 2-week delay completing RT due to immune toxicity DPRD. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, which grade severity from 1=mild to 5=death. Two alternate DSs with a delayed 2nd dose (to reduce/avoid doses concurrent with RT) would be tried if the initial DS was too toxic.
Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.
Overall survival (OS) time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
Locoregional progression is defined as local or regional progression or recurrence, death due to study cancer or unknown causes without documented progression. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure, distant metastasis (competing risk), deaths from other causes (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
Failure is defined as the occurrence of distant metastasis. Failure time is defined as time from randomization to first occurrence of distant metastasis, local or regional progression or recurrence (competing risk), death (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0008
- source section id
- NCT03258554-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year
- measure definition
- The EORTC QLQ C30 Physical Functioning score measures patient reported limitations in physical activities. Possible scores for each score range from 0 to 100, with higher scores indicating better physical functioning. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.
- time frame
- Baseline and one year after end of radiation therapy (approximately 7 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Randomized participants with baseline and one-year data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change in MD Anderson Dysphagia Inventory (MDADI) Composite Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0009
- source section id
- NCT03258554-om-0009
- source outcome index
- 9
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MD Anderson Dysphagia Inventory (MDADI) Composite Score at One Year
- measure definition
- The MDADI Composite score measures overall swallowing related quality of life derived from the emotional, functional, and physical scores, excluding the global item. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year after end of radiation therapy (approximately 7 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Randomized participants with baseline and one-year data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Change in the EORTC QLQ C30 Global Heath Status Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0015
- source section id
- NCT03258554-om-0015
- source outcome index
- 15
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the EORTC QLQ C30 Global Heath Status Score at One Year
- measure definition
- The EORTC QLQ C30 Global Heath Status score measures overall health related quality of life. Possible scores for each scale range from 0 to 100, with higher scores indicate better overall quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicate better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Change in the EORTC QLQ C30 Fatigue Score at One Year
Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0016
- source section id
- NCT03258554-om-0016
- source outcome index
- 16
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the EORTC QLQ C30 Fatigue Score at One Year
- measure definition
- The EORTC QLQ C30 fatigue score measures patient reported fatigue symptom burden. Possible scores for each score range from 0 to 100, with higher scores indicating worse fatigue. Change is defined as the time point score minus the baseline score, where negative values indicate improvement for and positive values indicate.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 0
- direction quote
- higher scores indicating worse
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Change in EORTC QLQ-C30 H&N35 Swallowing Score at One Year
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0017
- source section id
- NCT03258554-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in EORTC QLQ-C30 H&N35 Swallowing Score at One Year
- measure definition
- The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change in MDADI Global Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0018
- source section id
- NCT03258554-om-0018
- source outcome index
- 18
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Global Score at One Year
- measure definition
- The MDADI Global score measures patient reported overall swallowing related quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change in MDADI Emotional Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0019
- source section id
- NCT03258554-om-0019
- source outcome index
- 19
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Emotional Score at One Year
- measure definition
- The MDADI Emotional score measures the emotional impact of swallowing difficulties on quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change in MDADI Functional Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0020
- source section id
- NCT03258554-om-0020
- source outcome index
- 20
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Functional Score at One Year
- measure definition
- The MDADI Functional score measures the functional impact of swallowing difficulties on daily activities. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Unnamed quality-of-life measure · Change in MDADI Physical Score at One Year
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0021
- source section id
- NCT03258554-om-0021
- source outcome index
- 21
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Physical Score at One Year
- measure definition
- The MDADI Physical score measures the physical aspects of swallowing difficulties and their impact on swallowing related quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Change in EuroQol 5 Dimension 5 Level (EQ 5D 5L) Index Score at One Year
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0022
- source section id
- NCT03258554-om-0022
- source outcome index
- 22
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change in EuroQol 5 Dimension 5 Level (EQ 5D 5L) Index Score at One Year
- measure definition
- The EQ-5D-5L Index score measures health related quality of life based on responses to five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Possible scores range from 0 (worst health state) to 1(best health state). Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and 1 year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
PRO-CTCAE · Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0025
- source section id
- NCT03258554-om-0025
- source outcome index
- 25
- instrument
- PRO-CTCAE
- instrument basis
- matched 'pro-ctcae' in the study's own wording
- scale title
- Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- measure definition
- PRO-CTCAE is not intended for expedited reporting, real time review or safety reporting. PRO-CTCAE data are exploratory and not currently intended for use in data safety monitoring or adverse event stopping rules.
- time frame
- Up to 3 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0026
- source section id
- NCT03258554-om-0026
- source outcome index
- 26
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales
- measure definition
- The mean change from baseline at each time point will be summarized using mean and standard deviations for each arm. Mean change from baseline will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from baseline will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group. The same analysis will be conducted for between group comparisons at each time point.
- time frame
- Up to 12-24 months from end of RT
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- trial label
- Radiation Therapy With Durvalumab or Cetuximab in Treating Patients With Locoregionally Advanced Head and Neck Cancer Who Cannot Take Cisplatin
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 12
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0000
- source section id
- NCT03258554-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase]
- endpoint definition
- DLTs were collected to verify the safety of durvalumab with RT in this population. Safety was determined if ≤ 2 of 8 participants in the cohort had any DLT, in which case the study would proceed to phase II with that dose schedule (DS). The probability for the DS to be deemed too toxic, given a true toxicity rate ≥ 45%, is at least 78%. With a true toxicity rate ≤ 20%, the probability for the DS do be deemed safe is 80%. The full DLT definition does not fit here, but includes all grade 5 AEs, grade 3 or 4 AEs definitely or probably related to durvalumab (DPRD) except for specified AEs and situations, and incomplete or \> 2-week delay completing RT due to immune toxicity DPRD. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, which grade severity from 1=mild to 5=death. Two alternate DSs with a delayed 2nd dose (to reduce/avoid doses concurrent with RT) would be tried if the initial DS was too toxic.
- time origin
- From start of durvalumab to 4 weeks after radiation therapy, approximately 13 weeks. Weekly during RT, at RT end, prior to adjuvant durvalumab, one month after end of RT.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The first eight DLT evaluable participants in a given dose schedule cohort. An evaluable participant is defined as a participant who either (1) experienced a DLT and received at least one dose of durvalumab, or (2) received at least one dose of durvalumab and one fraction of radiation therapy (RT) and completed the DLT observation period (4 weeks after RT).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0001
- source section id
- NCT03258554-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary]
- endpoint definition
- Progression (failure) is defined as local, regional, or distant disease progression, or death from any cause. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure or last follow-up (censored). Failure rates are estimated using the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided. Analysis was planned to occur after 69 failure events had been reported.
- time origin
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0002
- source section id
- NCT03258554-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary]
- endpoint definition
- Overall survival (OS) time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
- time origin
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0003
- source section id
- NCT03258554-om-0003
- source outcome index
- 3
- endpoint
- Locoregional Failure (Percentage of Participants With Locoregional Failure)
- endpoint definition
- Locoregional progression is defined as local or regional progression or recurrence, death due to study cancer or unknown causes without documented progression. Progression was assessed by imaging, clinical assessment, or biopsy. Failure time is defined as time from randomization to failure, distant metastasis (competing risk), deaths from other causes (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
- time origin
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0004
- source section id
- NCT03258554-om-0004
- source outcome index
- 4
- endpoint
- Distant Metastasis (Percentage of Participants With Distant Metastasis)
- endpoint definition
- Failure is defined as the occurrence of distant metastasis. Failure time is defined as time from randomization to first occurrence of distant metastasis, local or regional progression or recurrence (competing risk), death (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
- time origin
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0005
- source section id
- NCT03258554-om-0005
- source outcome index
- 5
- endpoint
- Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer)
- endpoint definition
- Failure is defined as Death from second primary, protocol treatment, or "other cause". Failure time is defined as time from randomization to first occurrence of failure, death due to study cancer or unknown cause (competing risk), or last follow-up (censored). Failure rates are estimated using the cumulative incidence method. The protocol specifies that the distributions of failure times be compared between the arms, which is reported in the statistical analysis results. Two-year estimates are provided.
- time origin
- From randomization to last follow-up: weekly during RT, after end of RT: every 4 months for 1 year, every 6 months for 2 years, then annually. Additionally, every 4 weeks during adjuvant durvalumab. Maximum follow-up at time of analysis was 4.2 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0000
- arm key
- OG000
- arm label
- (Lead-in) RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 8
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0001
- arm key
- OG000
- arm label
- RT + Cetuximab
- regimen
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0001
- arm key
- OG001
- arm label
- RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0002
- arm key
- OG000
- arm label
- RT+ Cetuximab
- regimen
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0002
- arm key
- OG001
- arm label
- RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0003
- arm key
- OG000
- arm label
- RT+ Cetuximab
- regimen
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0003
- arm key
- OG001
- arm label
- RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0004
- arm key
- OG000
- arm label
- RT+ Cetuximab
- regimen
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0004
- arm key
- OG001
- arm label
- RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0005
- arm key
- OG000
- arm label
- RT+ Cetuximab
- regimen
- IMRT for seven weeks, 5 fractions/week. Cetuximab 400 mg/m\^2 IV starts one week prior to RT, then 250 mg/m\^2 weekly for seven additional cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 63
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- outcome key
- om-0005
- arm key
- OG001
- arm label
- RT + Durvalumab
- regimen
- IMRT for seven weeks, 5 fractions/week. Durvalumab 1500 mg IV starts two weeks prior to RT and continues every 4 weeks for a total of seven cycles in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 123
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03258554-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- harm key
- EG000
- source section id
- NCT03258554-ae
- event group key
- EG000
- event group label
- (Lead-in) RT + Durvalumab
- serious affected
- 4
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.
- event definition
- All-cause mortality was assessed in all enrolled participants. Adverse events were assessed in enrolled participants who started study treatment. CTCAE 4.0 was used in the lead-in component and CTCAE 5.0 was used in the phase II component.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- harm key
- EG001
- source section id
- NCT03258554-ae
- event group key
- EG001
- event group label
- RT + Cetuximab
- serious affected
- 51
- serious at risk
- 61
- other affected
- 61
- other at risk
- 61
- frequency threshold
- 0
- collection period
- Weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.
- event definition
- All-cause mortality was assessed in all enrolled participants. Adverse events were assessed in enrolled participants who started study treatment. CTCAE 4.0 was used in the lead-in component and CTCAE 5.0 was used in the phase II component.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- harm key
- EG002
- source section id
- NCT03258554-ae
- event group key
- EG002
- event group label
- RT + Durvalumab
- serious affected
- 84
- serious at risk
- 119
- other affected
- 118
- other at risk
- 119
- frequency threshold
- 0
- collection period
- Weekly during RT, RT end, from end of RT: months 1, (Cetuximab: 2, 3,) 4, 8, 12, 18, 24, 30, 36, then annually. Additionally, prior to each adjuvant durvalumab cycle. Maximum follow-up at time of analysis= 4.2 yr.
- event definition
- All-cause mortality was assessed in all enrolled participants. Adverse events were assessed in enrolled participants who started study treatment. CTCAE 4.0 was used in the lead-in component and CTCAE 5.0 was used in the phase II component.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0008
- source section id
- NCT03258554-om-0008
- source outcome index
- 8
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) Physical Functioning Score at One Year
- measure definition
- The EORTC QLQ C30 Physical Functioning score measures patient reported limitations in physical activities. Possible scores for each score range from 0 to 100, with higher scores indicating better physical functioning. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.
- time frame
- Baseline and one year after end of radiation therapy (approximately 7 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Randomized participants with baseline and one-year data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0009
- source section id
- NCT03258554-om-0009
- source outcome index
- 9
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MD Anderson Dysphagia Inventory (MDADI) Composite Score at One Year
- measure definition
- The MDADI Composite score measures overall swallowing related quality of life derived from the emotional, functional, and physical scores, excluding the global item. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year after end of radiation therapy (approximately 7 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Randomized participants with baseline and one-year data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0015
- source section id
- NCT03258554-om-0015
- source outcome index
- 15
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the EORTC QLQ C30 Global Heath Status Score at One Year
- measure definition
- The EORTC QLQ C30 Global Heath Status score measures overall health related quality of life. Possible scores for each scale range from 0 to 100, with higher scores indicate better overall quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement for and negative values indicate.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicate better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0016
- source section id
- NCT03258554-om-0016
- source outcome index
- 16
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in the EORTC QLQ C30 Fatigue Score at One Year
- measure definition
- The EORTC QLQ C30 fatigue score measures patient reported fatigue symptom burden. Possible scores for each score range from 0 to 100, with higher scores indicating worse fatigue. Change is defined as the time point score minus the baseline score, where negative values indicate improvement for and positive values indicate.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 0
- direction quote
- higher scores indicating worse
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0017
- source section id
- NCT03258554-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change in EORTC QLQ-C30 H&N35 Swallowing Score at One Year
- measure definition
- The EORTC QLQ-H\&N35 swallowing score measures patient-reported difficulty with swallowing various foods and liquid and ranges from 0 (no swallowing problems) to 100 (maximum swallowing difficulty). A positive change from baseline indicates worsening swallowing function.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0018
- source section id
- NCT03258554-om-0018
- source outcome index
- 18
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Global Score at One Year
- measure definition
- The MDADI Global score measures patient reported overall swallowing related quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0019
- source section id
- NCT03258554-om-0019
- source outcome index
- 19
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Emotional Score at One Year
- measure definition
- The MDADI Emotional score measures the emotional impact of swallowing difficulties on quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0020
- source section id
- NCT03258554-om-0020
- source outcome index
- 20
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Functional Score at One Year
- measure definition
- The MDADI Functional score measures the functional impact of swallowing difficulties on daily activities. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0021
- source section id
- NCT03258554-om-0021
- source outcome index
- 21
- instrument
- Unnamed quality-of-life measure
- instrument basis
- matched 'quality of life' in the study's own wording
- scale title
- Change in MDADI Physical Score at One Year
- measure definition
- The MDADI Physical score measures the physical aspects of swallowing difficulties and their impact on swallowing related quality of life. Possible scores range from 20 to 100, with higher scores indicating better swallowing related quality of life. Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and one year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- 1
- direction quote
- higher scores indicating better
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0022
- source section id
- NCT03258554-om-0022
- source outcome index
- 22
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change in EuroQol 5 Dimension 5 Level (EQ 5D 5L) Index Score at One Year
- measure definition
- The EQ-5D-5L Index score measures health related quality of life based on responses to five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Possible scores range from 0 (worst health state) to 1(best health state). Change is defined as the time point score minus the baseline score, where positive values indicate improvement and negative values indicate decline.
- time frame
- Baseline and 1 year
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0025
- source section id
- NCT03258554-om-0025
- source outcome index
- 25
- instrument
- PRO-CTCAE
- instrument basis
- matched 'pro-ctcae' in the study's own wording
- scale title
- Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- measure definition
- PRO-CTCAE is not intended for expedited reporting, real time review or safety reporting. PRO-CTCAE data are exploratory and not currently intended for use in data safety monitoring or adverse event stopping rules.
- time frame
- Up to 3 years
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-clinical-stage-iii-hpv-mediated-p16-positive-oropharyngeal-carcinoma-ajc
- nct id
- NCT03258554
- qol key
- qol-0026
- source section id
- NCT03258554-om-0026
- source outcome index
- 26
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales
- measure definition
- The mean change from baseline at each time point will be summarized using mean and standard deviations for each arm. Mean change from baseline will be compared between the arms using a two sample t test. If data normality assumptions are not met, the Wilcoxon rank sum test will be used to test the hypothesis. Mean change from baseline will be tested using an omnibus F test followed by individual comparisons of change scores at different time points within each treatment group. The same analysis will be conducted for between group comparisons at each time point.
- time frame
- Up to 12-24 months from end of RT
- analysis role
- exploratory
- reporting status
- NOT_POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice