Trial · NCT07441681
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression free survival (PFS) | From randomization until locoregional failure, distant failure, or death due to any cause, up to 8 years | The PFS rates for each treatment arm will be estimated in the overall sample and within each p16 subgroup using the Kaplan-Meier method. Estimates of the median PFS and 2-year PFS rates will be obtained with 90% confidence intervals. The comparison of PFS distributions between each treatment arm will be performed using a one-sided stratified log-rank test (stratified by the randomization stratification factors). As additional analysis of treatment effect, multivariable analysis will be performed using a Cox proportional hazards model, where the stratification factors, and relevant patient and tumor characteristics are included (as measured by the model's Bayesian Information Criterion \[BIC\]). Hazard ratios and their respective 90% confidence intervals will be provided. |
| Secondary | Overall survival (OS) | From randomization until death due to any cause, up to 8 years | Will be summarized by treatment arm using standard Kaplan-Meier methods, where estimates of the median and 2-year OS will be obtained with 90% confidence intervals. The OS will be compared using a one-sided stratified log-rank test, stratified by the randomization strata. |
| Secondary | OS by p16 status | From randomization until death due to any cause, up to 8 years | Assessments within p16 subgroups is to compare treatment arms within potentially clinically relevant subgroups. Within p16-negative and p16-positive subgroups, the OS will be summarized by study arm using standard Kaplan-Meier methods. The median OS and 2-year OS rates will be reported with 90% confidence intervals. Comparisons will be made using one-sided stratified log-rank tests. Multivariate Cox regression models will also be considered, where relevant covariates are selected based on the model's BIC. |
| Secondary | PFS by p16 status | From randomization until locoregional failure, distant failure, or death due to any cause, up to 8 years | PFS assessments within p16 subgroups is to compare treatment arms within potentially clinically relevant subgroups. Within p16-negative and p16-positive subgroups, the PFS will be summarized by study arm using standard Kaplan-Meier methods. The median PFS and 2-year PFS rates will be reported with 90% confidence intervals. Comparisons will be made using one-sided stratified log-rank tests. Multivariate Cox regression models will also be considered, where relevant covariates are selected based on the model's BIC. No adjustments will be made for multiplicity. |
| Secondary | Incidence of adverse events | Up to 24 months from end of radiation therapy (RT) | Adverse event grades will be assessed by Common Terminology Criteria for Adverse Events version 5.0. The overall (highest grade) adverse events will be summarized by treatment arm using frequencies and relative frequencies. |
| Secondary | Incidence of patient reported incidence of adverse events | Up to 12 months from end of RT | Patient responses will be summarized by treatment arm and time point using frequencies and relative frequencies. |
| Secondary | Time to locoregional failure | From randomization until first evidence of local, regional disease progression or recurrence, or death from study cancer, up to 8 years | Will compare patterns of failure and competing causes of death between treatment arms. The number and type of failures will be summarized by treatment arm using frequencies and relative frequencies. The time to failure will be summarized by treatment arm using the cumulative incidence method, where estimates of the 2-year failure rates will be obtained with 90% confidence intervals. Comparisons between treatment arms will be made using the stratified Gray's test. |
| Secondary | Time to distant failure | From randomization until first evidence of distant metastasis, up to 8 years | Will compare patterns of failure and competing causes of death between treatment arms. The number and type of failures will be summarized by treatment arm using frequencies and relative frequencies. The time to failure will be summarized by treatment arm using the cumulative incidence method, where estimates of the 2-year failure rates will be obtained with 90% confidence intervals. Comparisons between treatment arms will be made using the stratified Gray's test. |
| Secondary | Time to competing mortality | From randomization until death due to other or unknown causes, up to 8 years | Will compare patterns of failure and competing causes of death between treatment arms. The number and type of failures will be summarized by treatment arm using frequencies and relative frequencies. The time to failure will be summarized by treatment arm using the cumulative incidence method, where estimates of the 2-year failure rates will be obtained with 90% confidence intervals. Comparisons between treatment arms will be made using the stratified Gray's test. |
| Secondary | Longitudinal eating/speech profiles | At baseline, end of treatment, 4, 6 and 12 months from end of RT | Assessed via the Performance Status Scale for Head and Neck Cancer. The mean score change (relative to end of radiation treatment) for each of these subscales between arms will be compared at 12 months post-RT using a two-sample independent t-test with a two-sided significance level of 0.05. A Wilcoxon test will be used if normality assumption does not hold. Temporal trends and differences between arms at other time points will be assessed using mixed models with the following covariates: time, treatment arm and its interaction. |
| Other | Primary outcome treatment effect by sex | Up to 8 years | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided. |
| Other | Primary treatment outcome by race | Up to 8 years | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided. |
| Other | Primary treatment outcome by ethnicity | Up to 8 years | Estimates of treatment effect and the corresponding 95% confidence intervals will be provided. |
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
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GET https://conductscience.org/api/trials/v1/NCT07441681/registered