A Randomised, 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
A Randomised, 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
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.
Inclusion criteria:
Exclusion criteria:
Winston-Salem, North Carolina, United States
Ciudad Autonoma de Bs As, Argentina
Wooloongabba, Queensland, Australia
Vina de Mar, Chile
Budpest, Hungary
Karamsad,Anand, Gujarat, India
Mazagaon, Mumbai, India
Confreria (CN), Italy
Aichi, Nagoya, Japan
Chiba, Kashiwa, Japan
Hyogo, Akashi, Japan
Hyogo, Kobe, Japan
Kanagawa, Isehara, Japan
Miyagi, Natori, Japan
Osaka, Osaka, Japan
Tochigi, Shimotsuke, Japan
Tokyo, Koto-ku, Japan
Pozuelo de Alarcón, Madrid, Spain
Denbighshire, United Kingdom
Whitchurch, Cardiff, United Kingdom