A Phase 2/3 interventional study of Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID) and Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID) in Oropharynx Cancer, Oral Cancer and Hypopharynx Cancer, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Completed at 3 sites in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 2/3, Interventional, and Treatment
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.
Patients with a palpable N2b-c or N3 HNSCC strictly unresectable were randomized to receive either accelerated RT-CT delivering to the primary tumor 62-64 Gy / 5 weeks in 31-32 fractions of 2 Gy BID or very accelerated RT delivering 62-64 Gy in 31-32 fractions of 2 Gy BID and 22-23 days. In the accelerated RT-CT arm, 3 cycles of CDDP 100 mg/m2 were delivered at day 1, 16, 32 and 2 cycles of 5 Fu 1000 mg/m2 day 1 to 5 and 31 to 35. One month after completion of the concomitant RT-CT, 2 additional cycles of CDDP-5FU were given in patients responding (> 50%) to the initial course of RT-CT. The end points were event free survival and survival.
373 studies on the registry are indexed under Oropharyngeal Neoplasms; 97 are open to participants now.
This study's enrollment of 120 is above the median of 48 across 284 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
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Gustave Roussy, Cancer Campus, Grand Paris