Trial · NCT06706401
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 | Event Free Survival (EFS) | At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years | Event free survival (EFS) is defined as the time from randomisation to apparition of a documented relapse either local or regional or distant according to clinical or radiological assessment, or persistent residual disease including pathologically positive neck node, or death due to any cause. |
| Secondary | Local relapse Free Survival | At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years | Local relapse Free Survival (lrFS, at site of primary tumor) is defined as the delay from randomisation to first local relapse (i.e. primary site) or death. Patients without documented event will be censured at the last adequate visit or tumor evaluation. |
| Secondary | Regional relapse Free survival | At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years | Regional relapse Free survival (rrFS, in the neck) is defined as the delay from randomisation to first regional relapse (i.e. neck) or death. |
| Secondary | Metastasis Free Survival | At 6, 9, 15, 21 and 27 months from randomisation then annually assessed up to 2 years | Metastasis Free Survival (mFS) is the time between randomisation and apparition of first metastasis (date of metastatic diagnosis). Patients without documented event will be censured at the last tumour evaluation. |
| Secondary | Rate of pathologically positive lymph nodes | At 4 months from the completion of (chemo)-radiotherapy | Rate of pathologically positive lymph nodes at neck node dissection performed at 4 months after the completion of (chemo)-radiotherapy for those patients benefiting from a neck node dissection |
| Secondary | Event Free Survival (EFS) | At 4 months from the completion of (chemo)-radiotherapy | Event Free Survival (EFS) considering that pathologically positive neck node within 4 months post-randomisation will not be an event. |
| Secondary | Overall survival | Until up to 2 years follow-up of the last patient enrolled | Overall survival defined as the time from randomisation to death due to any cause. Patient without documented death at the time of analysis will be censored at the date of last known contact. |
| Secondary | Adverse events | From the date of first intake of study drug until 27 months after the randomisation of the last randomised patient | Incidence of any adverse events graded according to NCI-CTCAE V5.0 |
| Secondary | Patient quality of life (EORTC QLQ-C30) | At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration | To assess the impact of the proposed combinations on patient' quality of life in the target population (EORTC QLQ-C30) |
| Secondary | Patient quality of life (EQ5-DL) | At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration | To assess the impact of the proposed combinations on patient' quality of life in the target population (EQ5-DL) |
| Secondary | Patient quality of life (EORTC QLQ-H&N43) | At randomisation, at 6, 9, 15, 21 and 27 months after randomisation and30 days after the last study treatments administration | To assess the impact of the proposed combinations on patient' quality of life in the target population (EORTC QLQ-H\&N43) |
| Secondary | Health economic analysis | From the first patient enrolled to 2 years after treatment discontinuation of the last patient enrolled | To perform an economic analysis of the use of a tailored-RT with or without ATRA (Vesanoid). A cost-effectiveness methodology will be implemented, which involves computing costs and efficacy for each of the four treatment arms. |
| Secondary | Immunomonitoring | Cycle 1 Day 1 pre-dose of Vesanoid, Day 1 of radiotherapy and end of radiotherapy (8 to 10 weeks after randomisation) | To study the impact of treatment on lymphocytes number and function, including by assessing immunosenescence induction and to study blood biomarkers predictive of response/toxicity following treatment |
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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