Reduction of Treatment Breaks and Radiation-Induced Esophagitis and Pneumonitis Using Amifostine in Unresectable Non-Small Cell Lung Cancer Patients Receiving Definitive Concurrent Chemotherapy and Radiation Therapy: A Prospective Community-Based Clinical

Concurrent chemotherapy with daily thoracic radiation therapy is a common regimen used in patients with non-small cell lung cancer resulting in excellent response rates but with appreciable morbidity. Radiation-induced toxicities may increase the number of treatment breaks and then may limit the use of this aggressive treatment approach for some patients. We are conducting an open-label, multicenter trial determining the incidence of radiation treatment breaks and severity of treatment-related toxicities with the concurrent use of a cytoprotective agent. Approximately 15 to 20 sites in the United States will participate with a total of 200 patients. Patients will receive one of two chemotherapy regimens and daily radiation (1.8 to 2.0 Gy daily; total dose, 60 to 70 Gy) and amifostine 500 mg subcutaneously or intravenous push daily over a 6- to 7-week period. Patients will receive amifostine (Ethyol; MedImmune Inc, Gaithersburg, MD) 500 mg daily. The route of amifostine administration chosen at the time of patient registration must be adhered to throughout the study. In addition, all patients may receive consolidation chemotherapy consisting of intravenous docetaxel 75 mg/m2 once every 3 weeks for three courses, starting more than 30 but less than 60 days after the last dose of amifostine or thoracic radiation therapy, whichever is the last therapy discontinued. The objectives of this study are to determine the incidence of radiation treatment breaks and evaluate acute radiation esophagitis, acute radiation pneumonitis, chronic radiation pneumonitis, and pulmonary function in patients with measurable, medically inoperable non-small cell lung cancer stage II, unresectable stage IIIA, or IIIB disease receiving combined modality therapy and amifostine.