Randomized Trial of Concomitant Chemotherapy in Patients With Locally Advanced HNSCC Treated by Radiotherapy-erbitux
Phase 3
Completed
- Conditions
- HNSCC
- Interventions
- Registration Number
- NCT00609284
- Lead Sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Brief Summary
The aim of the trial is to study the efficacy of adding concomitant chemotherapy (carboplatin/5FU) to Erbitux-radiotherapy in patients with locally advanced head and neck cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
Inclusion Criteria
- Squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, larynx
- Stage III - IV (T0-T4, N0-N2b, M0)
- Not resected
- Karnofsky PS>=80
- Informed consent signed
Exclusion Criteria
- Contra indication to chemotherapy or cetuximab
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Radiotherapy Radiotherapy 70Gy, Erbitux 1 Carboplatin, 5FU concomitant Radiotherapy 70Gy, Erbitux, Carboplatin-5FU 1 Radiotherapy Radiotherapy 70Gy, Erbitux, Carboplatin-5FU 1 cetuximab Radiotherapy 70Gy, Erbitux, Carboplatin-5FU 2 cetuximab Radiotherapy 70Gy, Erbitux
- Primary Outcome Measures
Name Time Method Progression free survival 3 years
- Secondary Outcome Measures
Name Time Method Loco-regional control 3 years
Trial Locations
- Locations (5)
Centre hospitalier Annecy
🇫🇷Annecy, France
Centre hospitalier de Bretagne Sud
🇫🇷Lorient, France
Centre Jean Perrin
🇫🇷Clermont Ferrand, France
Centre Guillaume Le Conquerant
🇫🇷Le Havre, France
Institut Gustave Roussy
🇫🇷Villejuif, France