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Feasibility of Cetuximab (ERBITUX®) Associated With Concomitant Radio-chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer: a Phase II, Randomised Study
Phase II, randomised, controlled, non comparative study with 2 parallel groups: * Arm A: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemotherapy including 2 cycles of cisplatin and vinorelbine associated with a weekly cetuximab infusion during the radiotherapy. * Arm B: patients will receive induction chemotherapy (cisplatin and docetaxel) followed by a concomitant radio-chemothérapy including 2 cycles of cisplatin and etoposide associated with a weekly cetuximab infusion during the radiotherapy.
Details
| Lead sponsor | Institut de Cancérologie de la Loire |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 91 |
| Start date | 2009-09 |
| Completion | 2011-08 |
Conditions
- Non-Small-Cell Lung Carcinoma
Interventions
- cisplatin, vinorlebine, cetuximab
- cisplatine, etoposide, cetuximab
Primary outcomes
- rate of patients presenting at least one toxicity grade≥3 (excepted hematological toxicity and nausea-vomiting) — End of concomitant treatment (Day 71)
Countries
France