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

PHASE2RecruitingINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

October 11, 2024

Primary Completion Date

October 1, 2032

Study Completion Date

October 1, 2032

Conditions
Ovarian CancerFallopian Tube CancerPrimary Peritoneal CarcinomaClear Cell Carcinoma
Interventions
DRUG

3 cycles chemotherapy instead of 6 cycles chemotherapy

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.

DRUG

6 cycles chemotherapy

Standard chemotherapy as comparator

Trial Locations (46)

6020

RECRUITING

Universitätsklinik Innsbruck, Innsbruck

12559

RECRUITING

DRK-Kliniken Berlin-Köpenick, Berlin

13353

RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin

52074

RECRUITING

Universitätsklinikum Aachen, Aachen

53115

RECRUITING

ZAHO Bonn Onkologische Praxis, Bonn

55131

RECRUITING

Universitätsklinik der Johannes-Gutenberg Universität Mainz, Mainz

59423

RECRUITING

Christliches Klinikum Unna Mitte, Unna

65199

RECRUITING

Helios Dr. Horst Schmidt Kliniken Wiesbaden, Wiesbaden

Unknown

NOT_YET_RECRUITING

Cliniques Universitaires St. Luc, Brussels

NOT_YET_RECRUITING

Jessa ziekenhuis, Hasselt

NOT_YET_RECRUITING

UZ Leuven, Leuven

NOT_YET_RECRUITING

University Hospital Ostrava, Ostrava

NOT_YET_RECRUITING

General University Hospital in Prague, Prague

NOT_YET_RECRUITING

University Hospital Bulovka, Prague

NOT_YET_RECRUITING

Klinikum Mittelbaden Baden-Baden Bühl, Baden-Baden

NOT_YET_RECRUITING

Uniklinikum Bonn, Bonn

NOT_YET_RECRUITING

Klinikum Lippe, Detmold

NOT_YET_RECRUITING

Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth, Düsseldorf

NOT_YET_RECRUITING

Universitätsklinikum Freiburg, Freiburg im Breisgau

NOT_YET_RECRUITING

Universitätsklinik Göttingen, Göttingen

NOT_YET_RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

NOT_YET_RECRUITING

SLK-Kliniken Heilbronn, Heilbronn

NOT_YET_RECRUITING

Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel

NOT_YET_RECRUITING

Universitätsklinikum Leipzig, Leipzig

NOT_YET_RECRUITING

Diakonie Klinikum Schwäbisch Hall, Schwäbisch Hall

NOT_YET_RECRUITING

Policlinico St. Orsola Malpighi, Bologna

NOT_YET_RECRUITING

ASST Spedali Civili di Brescia, Brescia

NOT_YET_RECRUITING

ASST Lecco - Ospedale A. Manzoni, Lecco

NOT_YET_RECRUITING

IRCCS Istituto nazionale dei Tumori, Milan

NOT_YET_RECRUITING

AOU Cagliari, Monserrato

NOT_YET_RECRUITING

Istituto Oncologico Veneto (IOV), Padua

NOT_YET_RECRUITING

Azienda Ospedaliera Universitaria Pisana, Pisa

NOT_YET_RECRUITING

Azienda USL IRCCS Di Reggio Emilia, Reggio Emilia

NOT_YET_RECRUITING

AO Ordine Mauriziano, Torino

NOT_YET_RECRUITING

AOU Città della Salute e della Scienza di Torino - Ospedale Sant'Anna, Torino

NOT_YET_RECRUITING

Hospital General Universitario Dr. Balmis, Alicante

NOT_YET_RECRUITING

Hospital Virgen de las Nieves, Granada

NOT_YET_RECRUITING

Hospital Universitario Lucus Augusti, Lugo

NOT_YET_RECRUITING

CIOCC Clara Campal, Madrid

NOT_YET_RECRUITING

H. Althaia Manresa, Manresa

NOT_YET_RECRUITING

H.U. Virgen de la Macarena, Seville

NOT_YET_RECRUITING

Hospital Universitario Virgen del Rocío, Seville

NOT_YET_RECRUITING

Hospital Universitario Sant Joan de Reus, Tarragona

NOT_YET_RECRUITING

Hospital General Universitario de Valencia, Valencia

NOT_YET_RECRUITING

Hospital La Fe, Valencia

01307

RECRUITING

Universitätsklinikum Carl Gustav Carus, Dresden

All Listed Sponsors
collaborator

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

OTHER

lead

North Eastern German Society of Gynaecological Oncology

OTHER