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

Study Overview
=================
Brief Summary
-----------------
This study aims to carry out a multi-center, randomized controlled study on patients with recurrent ovarian cancer after PARPi maintenance, to explore the clinicopathological and molecular characteristics of patients with recurrent ovarian cancer after PARPi maintenance, and to clarify whether patients with recurrent ovarian cancer after PARPi maintenance for more than 6 months are sensitive to platinum drugs, and the value of secondary tumor cell reduction in such treatment, In order to provide evidence-based medicine basis for the standardized treatment mode of recurrent ovarian cancer after PARPi maintenance treatment.

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

Conditions
-----------------
Relapsed Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: Secondary cytoreduction
* Drug: Chemotherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondary cytoreduction followed by chemotherapy<br> | Procedure: Secondary cytoreduction<br>* Open surgery is conducted by senior clinicians in gynecological oncology. Operation time，location and number of relapsed lesions, location and number of excised lesions, Whether achieved R0 or not, and other information are recorded.<br>Drug: Chemotherapy<br>* chemotherapy<br>|
| Active Comparator: chemotherapy alone<br> | Drug: Chemotherapy<br>* chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival (PFS) | progression free survival | 18-24 months |