Very Intense Radiotherapy-Chemotherapy Regimen in Advanced HNSCC

Oral Cancer Clinical Trial

Official title: A Randomized Trial Evaluating a Very Intense Radiotherapy-Chemotherapy Regimen Versus a Very Accelerated Radiotherapy in Advanced Head and Neck Squamous Cell Carcinoma

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Hypopharynx Cancer
• Larynx Cancer
• Oral Cancer
• Oropharynx Cancer

• NCT number: NCT00162708
• Study type: Interventional
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 1996