RecruitingNot ApplicableNCT05607329

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


Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

400 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is for women with ovarian cancer (including fallopian tube and peritoneal cancers) that has come back after initial treatment including PARP inhibitor maintenance therapy. It compares doing a second surgery to remove as much tumor as possible (cytoreduction) followed by chemotherapy, versus chemotherapy alone. **You may be eligible if...** - You have first- or second-line recurrent ovarian, peritoneal, or fallopian tube cancer - Your cancer came back more than 6 months after completing platinum-based chemotherapy - You received PARP inhibitor maintenance therapy for more than 6 months before relapse - Your initial surgery achieved complete tumor removal (R0) - Your cancer has recurred in 5 or fewer isolated spots, with minimal fluid in the abdomen - Your performance status is ECOG 0 or 1 **You may NOT be eligible if...** - Your cancer came back within 6 months of chemotherapy - You have widespread or numerous recurrence sites - You have significant excess abdominal fluid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESecondary 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.

DRUGChemotherapy

chemotherapy


Locations(1)

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05607329


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