Objective To study whether intervention debulking surgery improves survival in patients with advanced ovarian cancer who have bulky (> 2 cm) residual disease after primary surgery.
Design A prospective multicentre randomised study.
Setting Hospitals in the West Midlands.
Subjects Ovarian cancer patients with bulky residual disease after primary surgery who are considered well enough to receive cis-platinum based chemotherapy and further surgery.
Methods Eligible patients were randomised to receive combination chemotherapy alone or combined with intervention debulking surgery.
Main outcome measure Survival was assessed using product limit method and log-rank test.
Results Seventy-nine patients were entered into the study. Thirty-seven patients were randomised to intervention debulking surgery, 25 (67%) of whom underwent intervention debulking surgery, which was performed a median of 13 weeks after primary surgery. The median survival for the intervention debulking surgery group was 15 months (95% CI 10–20 mo) and that of those randomised to chemotherapy alone, which was 12 months (95% CI 8–16 mo), were not significantly different (hazard ratio = 0.71; 95% CI 0.44–1.13).
Conclusion Intervention debulking surgery may not improve survival in patients with advanced ovarian cancer.