Conditions: Head and Neck Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 617
Healthy volunteers: no

Brief summary:
This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

Detailed description:

Arms:
arm 1: Once daily arm 2: Once daily

Interventions: intervention 1: Placebo intervention 2: Afatinib
Intervention descriptions: intervention 1: Once daily intervention 2: Once daily

Protocol document: