NCT03983226

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (estimated)
• Sponsor: Shanghai Gynecologic Oncology Group · Other Government
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.

Conditions

• Ovarian Cancer Recurrent
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-18
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2019-06-12
• Last updated: 2022-03-18

Locations

5 sites across 1 country: China