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

Fallopian Tube Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03983226
Study type Interventional
Source Shanghai Gynecologic Oncology Group
Contact Rong Jiang, M.D.
Phone +862164041990
Email jiang.rong@zs-hospital.sh.cn
Status Recruiting
Phase Phase 2
Start date October 18, 2019
Completion date December 2026
View Details
See also
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