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Secondary cytoreduction surgery for recurrent epithelial ovarian cancer patients after PARPi maintenance: A multicenter, randomized, controlled clinical trial
  1. Tingting Chen1,
  2. Junfen Xu2,
  3. Bairong Xia3,
  4. Hui Wang2,4 and
  5. Yuanming Shen1
  1. 1Department of Gynecologic Oncology, Women's Hospital,Zhejiang University School of Medicine, Hangzhou, China
  2. 2Department of Gynecologic Oncology, Women's Hosptial, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
  3. 3Department of Gynecology, University of Science and Technology of China, Hefei, Anhui, China
  4. 4Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
  1. Correspondence to Dr Yuanming Shen, Department of Gynecologic Oncology, Women's Hospital School of Medicine Zhejiang University, Hangzhou, China; 5312010{at}


Background Poly ADP-ribose polymerase inhibitors (PARPi) treatment has radically changed the treatment strategy for epithelial ovarian cancer. Cancer progression with PARPi maintenance is a new problem that has arisen in clinical practice, and the value of secondary cytoreduction surgery remains unknown.

Primary Objective To evaluate the benefits of secondary cytoreductive surgery and to clarify the sensitivity to platinum in patients with firstline or secondline recurrent epithelial ovarian cancer who have completed ≥6 months of PARPi maintenance.

Study Hypothesis Carefully selected patients who progress on PARPi maintenance will benefit from secondary cytoreductive surgery.

Trial Design This is a multicenter phase III trial. Eligible patients will be randomly assigned at a ratio of 1:1 to either the experimental or standard arm. Patients in the experimental arm will receive secondary cytoreductive surgery followed by platinum based chemotherapy, while patients in the standard arm will be provided with chemotherapy alone.

Major Inclusion/Exclusion Criteria Patients diagnosed with firstline or secondline recurrent epithelial ovarian cancer who had previously received ≥4 cycles of platinum based chemotherapy in initial treatment followed by PARPi maintenance therapy for ≥6 months prior to recurrence.

Primary Endpoint Progression free survival.

Sample Size 400 patients.

Estimated Dates for Competing Accrual and Presenting Results Accrual completion is expected in December 2024 with results mature after 2 years of follow-up in 2026.

Trial Registration NCT05607329

  • Ovarian Diseases
  • Surgical Oncology

Data availability statement

There are no data in this work.

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Data availability statement

There are no data in this work.

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  • TC and JX contributed equally.

  • Contributors Substantial contributions to the conception or design: YS, HW. Drafting the work or revising it critically for important intellectual content: TC, JX, BX. Final approval of the version published: YS. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: YS.

  • Funding The study is supported by Zhejiang Provincial Natural Science Foundation of China (LTGY23H160022), 4+X Clinical Research Project of Women's Hospital, Zhejiang University School of Medicine (ZDFY2022-4X201), Medical and Health Technology Program of Zhejiang Province (WKJ-ZJ-2113) and Key R&D Program of Zhejiang (2022C03013).

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.