CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 640 target
Drug / intervention
3 cycles chemotherapy instead of 6 cycles chemotherapy +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Female patient, age ≥18 years
  • ✓FIGO Stage III-IV high-grade ovarian cancer (all histological types except mucinous)
  • ✓Complete primary debulking without macroscopic residuals, confirmed by CT-Scan postoperatively
  • ✓HRD-positive: BRCAmut independent of NOGGO GIS Score OR NOGGO GIS Score >83 independent of BRCA status
Key exclusion· 30
  • ✕Non-epithelial origin, germ cell tumors, borderline tumors, or mucinous carcinoma
  • ✕Low-grade ovarian, fallopian tube or peritoneal cancer
  • ✕Known hypersensitivity to study drugs or excipients
  • ✕Known hypersensitivity to platinum-containing compounds other than carboplatin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05460000
NCT05460000Phase 2RecruitingOn TrackUpdated 4mo ago
CompareCT.gov

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 (N-Plus)

North Eastern German Society of Gynaecological Oncology·interventional·Posted Jul 15, 2022·Updated Feb 12, 2026

In Brief

A Phase 2 clinical trial evaluating 3 cycles chemotherapy instead of 6 cycles chemotherapy and 6 cycles chemotherapy for Ovarian Cancer and 3 related conditions. Currently recruiting, targeting 640 participants across 47 sites in 6 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Clear Cell Carcinoma
CountriesAustria, Belgium, Czechia, Germany, Italy, Spain
CollaboratorsInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Timeline

Phase 2Recruiting
20232024202520262027202820292030203120322033
First PostedJul 15, 2022
Enrollment StartOct 11, 2024
Primary CompletionOct 1, 2032
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 4.0 years agoPrimary completion in 6.2 years

Interventions

3 cycles chemotherapy instead of 6 cycles chemotherapydrug

We hypothesise that recurrence free survival in patients receiving 3 cycles of chemotherapy followed by maintenance with niraparib is not inferior to 6 cycles of chemotherapy followed by niraparib in advanced HRDpositive high-grade ovarian cancer patients with no residual tumor mass following primary tumor debulking.

6 cycles chemotherapydrug

Standard chemotherapy as comparator