NCT01233843

Chemoradiotherapy HNSCC, Randomized Study, Docetaxel,Cisplatin, 5FU,Erbitux.

A Phase III Randomized Multicenter Study,Comparing an Induction Chemotherapy Followed by Irradiation and Concurrent Erbitux Versus Chemoradiotherapy for Patients With Locoregional Advanced Head and Neck Cancers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that induction chemotherapy followed by radiation therapy plus Cetuximab will give better results than the validated treatment (chemoradiotherapy), for treatment of locoregional advanced head and neck cancers.

Detailed description

Concurrent chemoradiotherapy (radiotherapy+ carboplatin + 5FU) is a validated treatment for patients with locoregional advanced head and neck cancers. This study evaluates the outcome of induction chemotherapy (docetaxel, cisplatin, 5 FU) followed by radiation therapy + Erbitux for patients with head and neck carcinoma with almost one measurable lesion by RMI or CT scan. We hope we can improve the progression free survival of 14% at two years .

Conditions

• Squamous Cell Head and Neck Carcinoma

Interventions

Type	Name	Description
DRUG	carboplatin	70 mg per m2 and per day for four days. day 1; day 22; day 43
DRUG	5 fluorouracil	600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
RADIATION	radiation therapy	total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks

Timeline

• Start date: 2009-05-18
• Primary completion: 2018-11-06
• Completion: 2018-11-06
• First posted: 2010-11-03
• Last updated: 2019-01-18

Locations

1 site across 1 country: France