Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas
Phase 2
Terminated
- Conditions
- Head and Neck Cancer
- Interventions
- Radiation: chemoradiotherapy with cisplatin
- Registration Number
- NCT00169221
- Lead Sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Brief Summary
This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
- Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
- Patients receiving post-operative radiation (>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.
Exclusion Criteria
- previous history of cancer (except skin basal cell carcinoma)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description postop chemoradio with cisplatin chemoradiotherapy with cisplatin postoperative chemoradiotherapy with cisplatin postop chemoradio (cisplatin)+gefitinib Iressa (Gefitinib) postoperative chemoradiotherapy with cisplatin + gefitinib
- Primary Outcome Measures
Name Time Method Disease free survival 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Centre Antoine Lacassagne
🇫🇷Nice, France