NCT00162708

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 120 (planned)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Oropharynx Cancer
• Oral Cancer
• Hypopharynx Cancer
• Larynx Cancer

Interventions

Type	Name	Description
PROCEDURE	Radiotherapy 62-64 Gy in 5 W (31-32 f. of 2 Gy BID)
PROCEDURE	Radiotherapy 62-64 Gy in 22-23 D (31-32 f of 2 Gy BID)
DRUG	CDDP, 5 Fu

Timeline

• Start date: 1996-07-01
• First posted: 2005-09-13
• Last updated: 2005-09-13

Locations

3 sites across 1 country: France