A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy

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.

Trial Details

NCT ID

NCT05460000

Phase

PHASE2

Sponsor

North Eastern German Society of Gynaecological Oncology

Status

RECRUITING

Cancer Type

Ovarian Cancer

Interventions

3 cycles chemotherapy instead of 6 cycles chemotherapy
6 cycles chemotherapy

Locations (sample)

Innsbruck, Austria|47.26266,11.39454
Brussels, Belgium|50.85045,4.34878
Ghent, Belgium|51.05,3.71667
Hasselt, Belgium|50.93106,5.33781
Leuven, Belgium|50.87959,4.70093

Key Eligibility Criteria

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.

For full eligibility, visit ClinicalTrials.gov.

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