Trial · NCT07385079
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 | Failure-free survival (FFS) | 3 year | From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first |
| Secondary | Tumor response | the time of completion of induction chemotherapy, radiotherapy, and adjuvant immunotherapy; from the date of enrollment until the date of the last time that tumorimaging and assessment of disease has been done, assessed up to 62 weeks | Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians |
| Secondary | Overall survival (OS) | 3 years | From date of randomization until the date of death from any cause, whichever came first |
| Secondary | Distant metastasis-free survival (DMFS) | 3 years | From date of randomization until the date of first documented distant metastasis, whichever occurred first. |
| Secondary | Locoregional recurrence-free survival (LRRFS) | 3 years | From date of randomization until the date of first documented locoregional recurrence, whichever occurred first. |
| Secondary | Adverse events (AEs) and serious adverse events (SAEs) | 3 years | Graded according to CTCAE V5.0. |
| Secondary | Quality of life (QoL) | week 1, 6, 24, 60, 72 | The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual. For the functional scales and the global health status scale, a higher score represents a better level of functioning or quality of life. For the symptom scales, a higher score indicates a greater severity of symptoms. |
| Secondary | Failure-free survival (FFS) within different subgroups | 3 years | analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. \>4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage. |
| Other | Correlation between pre-treatment PD-L1 expression level and FFS | 3 years | Pre-treatment PD-L1 expression level of tumor cell is evaluated centrally by means of immunohistochemical testing. |
| Other | Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level | 3 years | Subgroup analysis |
| Other | Evaluate failure-free survival in the subgroup of clinical stage | 3 years | Subgroup analysis |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT07385079/registered