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RECRUITING
NCT03983226
PHASE2

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

Sponsor: Shanghai Gynecologic Oncology Group

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

167

Start Date

2019-10-18

Completion Date

2026-12

Last Updated

2022-03-18

Healthy Volunteers

No

Interventions

PROCEDURE

Surgery

Tumor debulking surgery (surgery in recurrent ovarian disease)

DRUG

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

Salvage chemotherapy

DRUG

Niraparib

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