Early Stage Ovarian Cancer: A Randomized Clinical Trial Comparing Whole Abdominal Radiotherapy, Melphalan, and Intraperitoneal Chromic Phosphate: A National Cancer Institute of Canada Clinical Trials Group Report

Two hundred fifty-seven eligible patients with stage I, IIA "high risk " ovarian carcinoma and IIB, 1110 (dis-ease confined to pelvis), were randomized to either total abdominal radiotherapy (arm A) 2,250 rad in 20 fractions (107 patients), melphalan (arm B) 8 mg/m 2/d x 4 every 4 weeks x 18 courses (106 pa-tients), or intraperitoneal chromic phosphate (arm C) 10 to 20 mCi (44 patients). All patients were initially treated with pelvic radiotherapy; arm A, 2,250 rad in ten fractions; and arms B and C, 4,500 rad in 20 fractions. Entry to arm C was discontinued early be-cause of toxicity. In a multifactor analysis using pro-portional hazards models, no significant difference in survival was observed although there was a margin-ally significant difference in disease-free surviva