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

Korábbi kezelés

• Received radiotherapy within 2 weeks before the start of the study intervention;

Más betegség

• Platinum-refractory/uncontrolled epithelial ovarian cancer;
• Non-epithelial ovarian tumor, mucinous, serous-mucinous (mainly mucinous), malignant Brenner tumor, low-grade serous carcinoma, borderline tumor;
• Suffering from other malignant tumors that have not achieved complete remission in the past 2 years;
• General conditions cannot tolerate secondary cytoreduction;
• Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.

• 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;
• Relapse occurred after 6 month since platinum-based chemotherapy;
• PARPi maintenance therapy for more than 6 months before relapse;
• R0 ideal debulking in initial surgery;
• PET-CT indicate the recurrence lesion is isolated and not exceed 5 sites, and the ascites is less than 500ml;
• ECOG/WHO Performance score of 0 to 1;
• No hepatic failure, bilirubin ≤ 1,5 time the Normal limit, ASAT and ALAT ≤ 3 time the Upper Normal Limit
• No Renal insufficiency (serum creatinine < 1,5 time the normal limit, creatinine clearance > 80 mL/min). calculated with MDRD method
• Hematology function: PNN ≥ 1,5x10⁹/L, platelets ≥ 100x10⁹/L
• No contraindication to general anaesthesia for heavy surgery
• Patients having read, signed and dated Informed consent before any study procedure