Trial · NCT03258554
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) [Lead-in Phase] | 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. | 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). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-free Survival (Percentage of Participants Alive Without Progression) [Phase II Primary] | 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. | Randomized participants | percentage of participants | NUMBER |
| PRIMARY | Overall Survival (Percentage of Participants Alive) [Originally Phase III Primary / Now Phase II Secondary] | 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. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Locoregional Failure (Percentage of Participants With Locoregional Failure) | 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. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Distant Metastasis (Percentage of Participants With Distant Metastasis) | 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. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Competing Mortality (Percentage of Participants Who Died Due to Causes Other Than Study Cancer) | 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. | Randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete or Partial Response at 4-month Scan Determined by Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 | Baseline and 4 months after end of RT (approximately 6.5 months) | Randomized participants with 4-month response assessed by PET | percentage of participants | NUMBER |
| SECONDARY | Number of Participants by Highest Grade Adverse Event Reported | From randomization to last follow-up: 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. | Randomized and started study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Quality of Life (QOL) Analysis | Baseline up to 12 months | |||
| SECONDARY | Change in Swallowing QOL Using Total Composite M. D. Anderson Dysphagia Inventory (MDADI) Score | Baseline up to 1 year | |||
| SECONDARY | Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline PD-L1 (Programmed Cell Death Ligand 1) Expression | From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported. | Randomized participants with CPS score. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (Percentage of Participants Alive Without Progression) by Baseline p16 Status | From randomization to date of progression or last follow-up, whichever occurs first. Maximum follow-up at time of analysis was 4.2 years. Two-year PFS estimates are reported. | Randomized participants with p16 status. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Secondary Biomarker Analysis | Baseline up to 4 months after RT | |||
| OTHER_PRE_SPECIFIED | Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Up to 3 years | |||
| OTHER_PRE_SPECIFIED | QOL Endpoints Using Other Items in EORTC QLQ/HN35, EQ5D and MDADI Subscales | Up to 12-24 months from end of RT |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03258554/outcomes