Comparing secondary surgery plus chemotherapy to chemotherapy alone for relapsed ovarian cancer after PARPi treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of secondary cytoreduction followed by chemotherapy compared to chemotherapy alone in patients with relapsed ovarian cancer who have undergone PARPi maintenance treatment. It is a multicenter, randomized controlled trial that aims to analyze the clinicopathological and molecular characteristics of these patients. The study will assess whether patients who have been on PARPi maintenance for over six months are sensitive to platinum-based drugs and the potential benefits of secondary tumor cell reduction. The goal is to provide evidence-based recommendations for treating recurrent ovarian cancer after PARPi maintenance.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

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

Where it's running

• Women's Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.