Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated March 18, 2022 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-06-10; most recent amendment 2022-03-04.
Status change: Not Yet Recruiting → Recruiting 2019-12-07
Trial Details
NCT Number NCT03983226
Lead Sponsor Shanghai Gynecologic Oncology Group
Collaborators: Fudan University, Shanghai Jiao Tong University School of Medicine, Zhejiang Cancer Hospital, Sun Yat-sen University
Conditions Ovarian Cancer Recurrent, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Enrollment 167 participants
Start Date 2019-10-18
Primary Completion 2025-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2022-03-18