High-Risk Early-Stage Ovarian Cancer Randomized Clinical Trial Comparing Cisplatin Plus Cyclophosphamide versus Whole Abdominal Radiotherapy

From 1985 to 1989 70 patients with high-risk FIGO Stage I-II ovarian carcinoma entered a randomized trial comparing chemotherapy (CT: cisplatin 50 mg/m2 + cyclophosphamide 600 mg/nr day 1 every 28 days for 6 courses) versus whole abdominal radiotherapy (WAR) given according to the open-field technique (43.2 Gy/24 fractions to the pelvis and 30.2 Gy to the upper abdomen). Protocol violations occurred in 8 patients randomized to WAR who received CT because of their own and/or physician's decision. Since protocol compliance was poor and accrual low the study was prematurely closed. Treatment-related toxicity for patients receiving CT was mild and tolerable, consisting chiefly of controllable grade 3 emesis (71%). Grade 3–4 diarrhea was experienced by 28% of patients treated with WAR: severe enteritis requiring hospitalization was observed in 2 patients. Late bowel obstruction requiring surgery was observed in I patient. At a median follow-up of 60 months, 21 patients died and 23 relapsed. Five-year survival was 71% and 53% (p =.16), while relapse- free survival was 14% and 50% (p =.07) for CT and WAR, respectively. Although no firm conclusion can be drawn from the present study, a short-term CT. including cisplatin, appears a safe treatment in comparison to WAR.