Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
Written informed consent and obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
Female patient, age ≥ 18 years.
FIGO Stage III-IV high-grade ovarian cancer (all histological types, except mucinous histology)
Complete primary debulked patients (without any macroscopic residuals), confirmed by CT-Scan postoperatively.
Non-epithelial origin of the ovary, the fallopian tube or the peritoneum (i.e., germ cell tumors) and Ovarian tumors of low malignant potential (e.g., borderline tumors), or mucinous carcinoma of the ovary.
Low-grade ovarian, fallopian tube or peritoneal cancer.
Has known hypersensitivity to any of the study drugs or any of the excipients of any of the study drugs.
Has known hypersensitivity to platin-containing compounds other than carboplatin.
North Eastern German Society of Gynaecological Oncology
Lead sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborator