Trial · NCT07904819
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 | Post-induction Therapy Complete Response Rate (post-IT CRR) | Within 9 to 21 days after the last dose of induction therapy | The proportion of patients achieving complete response following induction therapy |
| Primary | Event-Free Survival (EFS) in the High-Risk Group | 3 years & 5 years | The time from the date of enrollment to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause. |
| Secondary | Overall survival (OS) | 3 years & 5 years | From date of enrollment to date of death from any cause |
| Secondary | Distant Metastasis-Free Survival (DMFS) | 3 years & 5 years | From the date of enrollment to the date of first documented distant metastasis or death from any cause, whichever occurs first. |
| Secondary | Locoregional Recurrence-Free Survival (LRRFS) | 3 years & 5 years | From the date of enrollment to the date of first documented locoregional recurrence or death from any cause, whichever occurs first. |
| Secondary | Adverse Events (AEs) | 3 years & 5 years | Graded according to CTCAE V5.0 |
| Secondary | Patient-Reported Adverse Events (PRO-CTCAE) | At the end of each treatment cycle (each cycle is 21 days), from Cycle 1 of induction therapy through Cycle 5 of adjuvant therapy | Patient-reported adverse events will be assessed using selected items from the National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI PRO-CTCAE™), Chinese version, administered at each treatment cycle. Patients will self-report and rate the severity of relevant adverse events throughout the study treatment period. |
| Secondary | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score | At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy | Assesses general quality of life in cancer patients. Items are scored and linearly transformed to a 0-100 scale. For functional scales, higher scores indicate better functioning; for symptom scales, higher scores indicate greater symptom burden. |
| Secondary | EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1) | At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy | Assesses head and neck cancer-specific symptoms. Items are scored and linearly transformed to a 0-100 scale. Higher scores indicate more severe symptoms. |
| Secondary | Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4) | At baseline, after completion of induction therapy (Week 10), at the end of IMRT (Week 16), at the last adjuvant cycle (Week 31; each cycle is 21 days), and at 1, 3, 12, 24, 36, 48, and 60 months post-radiotherapy | Assesses quality of life specific to head and neck cancer patients. Items are rated on a 0-4 scale and summed to a total score of 0-156. Higher scores indicate better quality of life. |
| Other | Correlation of Tumor, Peripheral Blood, and Fecal Biomarkers with Treatment Efficacy and Patient Prognosis | 3 years & 5 years | Tumor tissue biomarkers: PD-L1 expression level, tumor-infiltrating lymphocyte (TIL) density, immune score, expression profiles of immune checkpoint molecules and immune cell subpopulations, and tumor cell transcriptomic gene expression； Peripheral blood biomarkers: Immune cell populations, immune repertoire, and cytokine profiles； Fecal biomarkers: Composition and characteristics of fecal biomarkers in relation to treatment response and prognosis |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07904819/registered