Spots Global Cancer Trial Database for Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)

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Trial Identification

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

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

Study ID: NCT03983226

Conditions

Ovarian Cancer Recurrent

Fallopian Tube Cancer

Primary Peritoneal Carcinoma

Interventions

Surgery

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

Niraparib

Study Description

Brief 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.