A Phase II, Randomized Study of Cytoreductive Surgery Combined With Niraparib Maintenance in Platinum-sensitive, Secondary Recurrent Ovarian Cancer
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.
• 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)
‣ Cohort 1 and Cohort 3: No prior use of PARP inhibitor.
⁃ Cohort 2: Prior use of PARP inhibitor.
⁃ Cohort 3: No prior use of PARP inhibitor.
• Secondary cytoreductive surgery (SCR) when first recurrence
‣ Cohort 1 and Cohort 2: Never received SCR
⁃ Cohort 2: Never received SCR
⁃ Cohort 3: Received SCR
• Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. Single or localized lesions identified by CT, or MRI, or positron emission tomography/computed tomography (PET/CT). PI and Co-PI reach consensus if extensive lesions or carcinomatosis.
• It can be included if single lesion outside the peritoneal cavity can be resected.
• No more than 3 disease lesions by central-reviewed PET/CT imaging if the participated center has never participated in any surgical trials on ovarian cancer before.
• Patients who have given their signed and written informed consent and their consent.