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Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Sponsor: Shanghai Gynecologic Oncology Group
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
Surgery
Tumor debulking surgery (surgery in recurrent ovarian disease)
carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
Salvage chemotherapy
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