Treatment
This study consists of two different treatment options:
- Paclitaxel/carboplatin + maintenance niraparib
- Paclitaxel/carboplatin/bevacizumab + maintenance niraparib/bevacizumab
The patient will be randomly allocated to one of the treatment groups on a 1:1 ratio.
Treatment duration
Total bevacizumab duration of therapy is 15 months. The total duration of niraparib treatment is 2 years.
Eligibility
Main inclusion criteria:
- Patient with newly diagnosed:
- a. Ovarian cancer, primary peritoneal cancer and/or fallopian-tube cancer
- b. Histologically confirmed (based on local histopathological findings):
- high grade serous or
- high grade endometrioid (grade 2 and 3) or
- other epithelial non mucinous and non-clear cell ovarian cancer in a patient with germline BRCA 1 or 2 deleterious mutation
- c. At an advanced stage: FIGO stage IIIA to IIIC of the 2018 FIGO classification.
- Patient having undergone frontline, complete cytoreductive surgery
- Patient eligible for bevacizumab treatment in combination with chemotherapy and in maintenance. It must be started at the second chemotherapy cycle and be administered at a dose of 15mg/kg every 3 weeks up to a total of 15 months.
- An Eastern Cooperative Group (ECOG) performance status ≤1
Main exclusion criteria:
- Patient with clear cell adenocarcinoma or carcinosarcoma, non-epithelial origin of the ovarian tumor, the fallopian tube or the peritoneal tumor (i.e. germ cell tumors)
- Ovarian tumor of low malignant potential (e.g. borderline tumor), or mucinous carcinoma.
- Patient with synchronous high grade serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium is not eligible.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05183984). 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