Secondary Cytoreduction Followed by Chemotherapy Versus Chemotherapy Alone in Relapsed Ovarian Cancer After PARPi Maintenance Treatment: a Multicentre, Open-label, Randomised, Phase 3 Trial
Relapsed Ovarian Cancer
About this trial
This is an interventional treatment trial for Relapsed Ovarian Cancer
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; Received radiotherapy within 2 weeks before the start of the study intervention; General conditions cannot tolerate secondary cytoreduction; Severe hypersensitivity reactions (≥ grade 3) to paclitaxel or platinum and/or any of its excipients.
Sites / Locations
- Women's Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Secondary cytoreduction followed by chemotherapy
chemotherapy alone