A Randomized, Double-Blind, Placebo-Controlled, Phase III Study To Evaluate The Efficacy And Safety Of Afatinib (BIBW 2992) As Adjuvant Therapy After Chemo-Radiotherapy In Primary Unresected Patients With Stage III, IVa, Or IVb Loco-Regionally Advanced Head And Neck Squamous Cell Carcinoma.
To investigate the efficacy and safety of afatinib over placebo when given as adjuvant therapy after chemo-radiotherapy (CRT) in primary unresected patients with locoregionally advanced squamous cell carcinoma Stage III or IVa/b of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa/b.
-confirmed loco-regionally advanced squamous cell carcinoma, stage III, IVa/b of the oral cavity, oropharynx, or hypopharynx, or larynx stage IVa/b -unresected tumor prior to chemo-radiotherapy -concomitant platinum-based chemo-radiotherapy completed no longer than 16 weeks prior to randomisation -no evidence of disease at randomisation -good organ and physical function -patients with smoking history of less than or equal to to 10 pack years and with primary tumor site of base of tongue or tonsil are excluded -primary cancer of nasopharynx, sinuses, or salivary glands are excluded -prior treatment with EGFR-targeted small molecules, EGFR- targeted antibodies, and/or any investigational agents for treatment of head and neck cancer, are not allowed
Afatinib is an oral tyrosine kinase inhibitor taken once daily, starting at a dose of 40mg/day. The dose may be increased to 50mg/day and/or reduced to 40, 30, or 20mg/day according to absence or presence of drug-related adverse events. Treatment is continuous for up to 80 weeks (about 18 months)in the absence of unacceptable adverse events or tumor recurrence. Visits are weekly in the first month and then monthly. Scans are performed every 4 months. Quality of life questionnaires are taken throughout the study.
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