Trial · NCT07888816
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 12-Month Progression-Free Survival | 12 months | 12-month progression-free survival will be estimated using the Kaplan-Meier method. The proportion of patients progression-free at 12 months will be compared to the historical benchmark of 17%. The study will be considered positive if the lower bound of the 95% confidence interval exceeds 17%. |
| Secondary | 12-Month Modified Progression-Free Survival (mPFS) | 12 months | Modified progression-free survival is defined as the time from study enrollment to disease progression that is no longer amenable to local salvage radiotherapy or death from any cause, whichever occurs first. |
| Secondary | Treatment-Related Adverse Events | 12 Months | The incidence, severity, and type of acute and late treatment-related adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0. |
| Secondary | Changes in Patient-Reported Quality of Life | 12 Months | Assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) with higher scores indicating better quality of life. Changes from baseline will be assessed at each study time point. |
| Secondary | Changes in Patient-Reported Quality of Life and Functional Outcomes | 12 Months | Assessed using the EORTC Head and Neck Cancer Module (QLQ-H\&N43). Scores range from 0 to 100 scale where for the functional scales, higher scores indicate better functioning. For symptom scales and symptom items, higher scores indicate greater symptom burden or worse symptoms. Changes from baseline over the study period will be evaluated. |
| Secondary | Swallowing Function | 12 Months | Swallowing function will be assessed using the Functional Oral Intake Scale (FOIS), where scores range from 1 to 7, where 1 indicates no oral intake (nothing by mouth) and 7 indicates a full oral diet with no restrictions. Higher scores indicate better oral intake and swallowing function. Changes from baseline over the study period will be evaluated. |
| Secondary | Changes in Patient-Reported Quality of Life and Functional Outcomes | 12 Months | Assessed using the Performance Status Scale for Head and Neck Cancer (PSS-HN), which evaluates three domains: Normalcy of Diet, Eating in Public, and Understandability of Speech. Each domain is scored separately on a scale from 0 to 100, with higher scores indicating better function and less impairment. Changes from baseline over the study period will be evaluated. |
| Secondary | Median Progression-Free Survival (PFS) | 12 months | Estimated using the Kaplan-Meier method with 95% confidence intervals |
| Secondary | Median Overall Survival (OS) | 12 months | Estimated using the Kaplan-Meier method with 95% confidence intervals |
| Secondary | Objective Response Rate (ORR) | 12 months | Reported as a proportion with 95% confidence intervals |
| Secondary | Duration of Response (DoR) | 12 months | Estimated using the Kaplan-Meier method with 95% confidence intervals |
| Secondary | Time to Next Systemic Therapy | 12 months | Estimated using the Kaplan-Meier method, with patients censored at last contact if they have not initiated next-line therapy |
| Secondary | Health Economic Impact | 12 months | Health economic outcomes will be assessed through measures of healthcare resource utilization (Total treatment visits, imaging utilization, resource utilization) compared to historical conventional palliative RT cohorts. |
| Secondary | Financial Toxicity | 12 months | Patient-reported financial toxicity using Financial Toxicity Questionnaire, with higher scores indicating less financial distress (better financial well-being) and lower scores indicating greater financial toxicity (worse financial burden). |
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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