About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years to ≤ 75 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with platinum-sensitive, secondary relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
Disqualifiers
Patients with borderline tumors as well as non-epithelial tumors.
Patients for interval-debulking, or for second- or third-look surgery, or palliative surgery planned.
Impossible to assess the resectability. Radiological signs suggesting complete resection is impossible.
Patients who have received more than two previous regimen of chemotherapy (maintenance is not considered a third regimen).
Trial design
Treatments tested in this trial
- Surgery
- carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...
- Niraparib
Treatment groups
Sponsors and collaborators
Shanghai Gynecologic Oncology Group
Lead sponsor
Fudan University
Collaborator
Shanghai Jiao Tong University School of Medicine
Collaborator
Zhejiang Cancer Hospital
Collaborator
Sun Yat-sen University
Collaborator