This randomized study was conducted by Gynecologic Oncology Group to evaluate the role of secondary cytoreductive surgery in advanced epithelial ovarian carcinoma (EOC). Between June, 1994 to Jan, 2001, 550 patients of stage III and IV epithelial ovarian cancer with residual intraperitoneal tumour more than 1 cm after primary debulking surgery were enrolled in the study. Postoperatively patients received 3 cycles of chemotherapy using cisplatin and paclitaxel. Following this, 448 patients were randomized either to secondary cytoreductive surgery followed by 3 cycles of chemotherapy (n = 226) or 3 cycles of chemotherapy alone (n = 222). 102 of 550 patients did not undergo randomization either due to disease progression (n = 26), died (n = 16), medical contraindications (n = 20), declined (n = 18), presence of extra peritoneal tumour >1 cm (n = 16), excessive delay before randomization (n = 4) or other reasons (n = 2). After randomization, 24 patients were found ineligible (10 in surgery-chemotherapy arm, and 16 in the chemotherapy alone arm either due to inappropriate primary cancer (n = 10), inappropriate stage (n = 7), detection of second primary cancer (n = 3), or incomplete pre-study work up (n = 4). Thus, out of 424 randomized eligible patients, 216 were assigned to cytoreductive surgery followed by chemotherapy arm and 208 to chemotherapy alone. During secondary surgery, maximal effort was made to resect all gross tumours and surgery was performed within 6 weeks of completion of 3rd cycle of chemotherapy.
