RecruitingPhase 2NCT03983226

Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer


Sponsor

Shanghai Gynecologic Oncology Group

Enrollment

167 participants

Start Date

Oct 18, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether surgery to remove recurrent ovarian cancer (when it comes back a second time) followed by the PARP inhibitor niraparib improves outcomes compared to drug treatment alone, in patients with platinum-sensitive ovarian cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have ovarian, peritoneal, or fallopian tube cancer that has come back a second time and is still sensitive to platinum-based chemotherapy - A surgeon has assessed that complete removal of all visible cancer is possible - Depending on your cohort: you may or may not have previously used a PARP inhibitor or had prior cytoreductive surgery **You may NOT be eligible if...** - Complete surgical removal is not feasible - Your cancer is not platinum-sensitive - Your performance status or organ function does not meet requirements 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

PROCEDURESurgery

Tumor debulking surgery (surgery in recurrent ovarian disease)

DRUGcarboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...

Salvage chemotherapy

DRUGNiraparib

Niraparib maintenance therapy


Locations(5)

Fudan University Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Fudan University

Shanghai, China

Shanghai Jiao Tong University

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT03983226


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