Trial · NCT03811015
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | From randomization to death, assessed up to 10 years | Log rank test will be used to compare OS. As patients on the observation arm are allowed to cross-over to the nivolumab arm upon progression, an overall survival analysis using inverse probability censoring weights (IPCW, Robins et. al, 2000) will also be considered. Kaplan-Meier method and Cox regression will be used for the survival outcome analyses. |
| Primary | Negative (standardized qualitative) 12 week post therapy (cisplatin + radiation therapy [RT]) FDG positron emission tomography/computed tomography (PET/CT) associated with OS for patients who have a PET/CT | At 12 weeks post therapy | Logrank tests and input hazard rates will be used. |
| Primary | Negative (standardized qualitative) 12 week post therapy (cisplatin + RT) FDG PET/CT associated with PFS for patients who have a PET/CT | At 12 weeks post therapy | Logrank tests and input hazard rates will be used. |
| Secondary | Progression-free survival (PFS) | From randomization to date of progression, second primary tumor from the head and neck region, or death, assessed up to 10 years | Progression will be defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The comparison of PFS will use stratified log rank test and will be intent-to-treat analyses. |
| Secondary | Prognostic effect of baseline PD-L1 expression (positive versus [vs.] negative) on OS and PFS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic effect of baseline saliva and/or plasma human papillomavirus (HPV) status (positive vs. negative) on OS and PFS | Baseline up to 10 years | Saliva and plasma HPV status at 12 weeks and 9 months following completion of concurrent therapy will also be analyzed regarding effect on outcome. Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic value of maximum standardized uptake value (SUVmax) of primary tumor or neck nodal metastasis of baseline FDG PET/CT for OS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Prognostic value of SUVmax of primary tumor or neck nodal metastasis of baseline FDG PET/CT for PFS | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | SUVmax of primary tumor or nodal metastasis of baseline FDG PET/CT with PD-L1 expression (positive vs. negative) | Baseline up to 10 years | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | Post therapy (cisplatin + RT) FDG PET/CT with saliva or plasma levels of HPV deoxyribonucleic acid (DNA) | Up to 9 months post-therapy | Chi-square testing or Pearson correlation testing will be used for the secondary correlation analyses. |
| Secondary | PET based therapy response assessment compared to RECIST 1.1 assessment for patients who have a PET/CT scan at 12 weeks | At 12 weeks post chemoradiation therapy | Kappa statistics will be applied to evaluate the agreement between PET based therapy response assessment (Hopkins criteria) and RECIST 1.1 assessment at 12 weeks post chemoradiation therapy. |
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.
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