Phase III study of radiation therapy with or without cis-platinum in patients with unresectable squamous or undifferentiated carcinoma of the head and neck: an intergroup trial of the Eastern Cooperative Oncology Group (E2382).

Purpose: The Head and Neck Intergroup conducted a Phase III randomized trial to determine whether the addition weekly cisplatin to daily radiation therapy (RT) would improve survival in patients with unresectable squamous cell head-and-neck carcinoma.

Methods And Materials: Eligible patients were randomized to RT (70 Gy at 1.8-2 Gy/day) or to the identical RT with weekly cisplatin dosed at 20 mg/m(2).