Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03905902
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
* Without disease progression during preceding platinum-based chemotherapy
* Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression.
* First relapse identified by the criteria above up to 28 days prior to study randomization
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Known BRCA (breast cancer susceptibility gene) mutation status before randomization
* Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi
Exclusion Criteria:
* Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed
* Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy
* Intention to treat with intra-peritoneal chemotherapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03905902
Study Brief:
Protocol Section:
NCT03905902