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A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02 (BIBW2992ORL)
The purpose of this study is to evaluate the efficacy and safety of Afatinib in maintenance therapy after post-operative radiochemotherapy (66 Gy and Cisplatin at the dose of 100mg/m2 every 3 weeks)in squamous cell carcinoma of the head and neck.
Details
| Lead sponsor | Centre Leon Berard |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 134 |
| Start date | 2011-09 |
| Completion | 2021-05 |
Conditions
- Head and Neck Squamous Cell Carcinoma
Interventions
- AFATINIB
- Placebo of AFATINIB
Primary outcomes
- Disease Free Survival 2 years after the end of radiotherapy — 2 years after the end of radiotherapy
Countries
France