NCT05607329

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	Secondary cytoreduction	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.
DRUG	Chemotherapy	chemotherapy

Timeline

• Start date: 2021-05-01
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2022-11-07
• Last updated: 2022-11-07

Locations

1 site across 1 country: China