Trial Information
CARISSA Trial - Multicenter Randomized Phase II Trial Comparing Post-operative Radiotherapy and Cisplatin Alone or in Combination With the EGFR Inhibitor ZD 1839 (Iressa) in Upper Aerodigestive Tract Carcinomas
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Rene-Jean Bensadoun, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Antoine Lacassagne
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GORTEC 2004-02
NCT ID:
NCT00169221
Start Date:
September 2005
Completion Date:
July 2011
Related Keywords:
- Head and Neck Cancer
- Carcinoma
- Head and Neck Neoplasms