At a glance
ClinicalIndex Comparison Record- ✓Age between 18 and 75 years
- ✓ECOG performance status 0 to 2
- ✓Platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
- ✓Front-line or second-line treatment may have included bevacizumab or PARP inhibitor maintenance
- ✕Borderline tumors or non-epithelial tumors
- ✕Planned interval-debulking, second/third-look surgery, or palliative surgery
- ✕Impossible to assess resectability or radiological signs suggesting complete resection impossible
- ✕More than two previous chemotherapy regimens (maintenance not counted as third)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT03983226Phase 2RecruitingUpdate OverdueUpdated 51mo ago · Completion was 13mo agoA Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
In Brief
A Phase 2 clinical trial evaluating Surgery, carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin..., and 1 other intervention for Ovarian Cancer Recurrent and 2 related conditions. Currently recruiting, targeting 167 participants across 5 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Tumor debulking surgery (surgery in recurrent ovarian disease)
Salvage chemotherapy
Niraparib maintenance therapy