Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial

Inclusion Criteria

• •1. Patients with diagnosis of first-line or second-line recurrent epithelial ovarian carcinoma, peritoneal carcinoma, or fallopian tube carcinoma, who has previously received at least 4 cycles of platinum-based chemotherapy in initial treatment;
• •2. Relapse occurred after 6 month since platinum-based chemotherapy;
• •3. PARPi maintenance therapy for more than 6 months before relapse;
• •4. R0 ideal debulking in initial surgery;
• •5. PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
• •6. ECOG/WHO Performance score of 0 to 1;
• •7. No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
• •8. No Renal insufficiency (serum creatinine \< 1,5 time the normal limit, creatinine clearance \> 80 mL/min). calculated with MDRD method
• •9. Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
• •10. No contraindication to general anaesthesia for heavy surgery
• •11. Patients having read, signed and dated Informed consent before any study procedure