Treatment
This study consists of two different treatment options:
- Arm A: 3 cycles carboplatin + paclitaxel maintenance therapy with niraparib
- Arm B: 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib
The patient will be randomly allocated to one of the treatment groups on a 1:1 ratio.
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- 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.
- Patients must have formalin-fixed, paraffin-embedded tumor samples available from the primary cancer for central NGS analysis and must be HRDpositive defined as BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score >83 independent of BRCA status, based on these results.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Main exclusion criteria:
- 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.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05460000). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be