Clinical trial · Interventional
Very Intense Radiotherapy-chemotherapy Regimen in Advanced HNSCC
A Randomized Trial Evaluating a Very Intense Radiotherapy-chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Altered fractionated radiotherapy and concomitant radio-chemotherapy have been shown to be two possibilities for improving efficacy of radiotherapy in locally advanced head and neck carcinomas. In this multicentric study, we tested the hypothesis that accelerated radiotherapy could be delivered concomitantly with conventional high doses of CDDP-5FU, aiming to improve both local control and on distant metastases as compared to very accelerated radiotherapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypopharynx Cancer | Malignant Hypopharyngeal Neoplasm | ALIAS | 0.90 |
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CDDP, 5 Fu | Drug | — | UNRESOLVED |
| Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) | Procedure | — | UNRESOLVED |
| Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event free survival (event = progressive disease or relapse or or death from any cause)
Secondary outcomes (2)
- measure
- Survival
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * palpable N2b-c or N3 (UICC 1997) squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx or larynx) * primary tumor and / or nodal extension strictly inoperable due to the extension of the disease * performance status of 0 to 2 (WHO scoring system) * renal/liver/cardiac functions and blood counts compatible with the use of CDDP and 5-FU * signed inform consent Exclusion Criteria: * distant metastasis * previous history of cancer * previous radiotherapy or chemotherapy
References
Publications (1)
- RESULTBourhis J, Lapeyre M, Tortochaux J, Lusinchi A, Etessami A, Ducourtieux M, Geoffrois L, Domenge C, Verrelle P, Wibault P, Janot F, Temam S, Blanchard P, Tao YG, Auperin A. Accelerated radiotherapy and concomitant high dose chemotherapy in non resectable stage IV locally advanced HNSCC: results of a GORTEC randomized trial. Radiother Oncol. 2011 Jul;100(1):56-61. doi: 10.1016/j.radonc.2011.07.006. Epub 2011 Aug 8. PMID 21831465