RecruitingPhase 2NCT05460000

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

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)

Sponsor

North Eastern German Society of Gynaecological Oncology

Enrollment

640 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer Clear Cell Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing whether 3 cycles versus 6 cycles of platinum-based chemotherapy before starting niraparib maintenance therapy gives similar outcomes in women with advanced ovarian cancer that has a specific DNA repair defect (called HRD-positive). The goal is to see if a shorter chemotherapy course is just as effective. **You may be eligible if...** - You are female and at least 18 years old - You have Stage III or IV high-grade ovarian, fallopian tube, or primary peritoneal cancer (not mucinous type) - Your tumor tested positive for HRD (homologous recombination deficiency) - You had complete removal of visible tumor during surgery **You may NOT be eligible if...** - You have a mucinous histology ovarian cancer - You have residual tumor after surgery - Your tumor does not have HRD - You have had prior chemotherapy for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG3 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.

DRUG6 cycles chemotherapy

Standard chemotherapy as comparator

Locations(47)

Universitätsklinik Innsbruck

Innsbruck, Austria

Cliniques Universitaires St. Luc

Brussels, Belgium

UZ Gent

Ghent, Belgium

Jessa ziekenhuis

Hasselt, Belgium

UZ Leuven

Leuven, Belgium

University Hospital Ostrava

Ostrava, Czechia

General University Hospital in Prague

Prague, Czechia

University Hospital Bulovka

Prague, Czechia

Universitätsklinikum Aachen

Aachen, Germany

Klinikum Mittelbaden Baden-Baden Bühl

Baden-Baden, Germany

DRK-Kliniken Berlin-Köpenick

Berlin, Germany

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

Berlin, Germany

ZAHO Bonn Onkologische Praxis

Bonn, Germany

Uniklinikum Bonn

Bonn, Germany

Klinikum Lippe

Detmold, Germany

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Florence-Nightingale-Krankenhaus Düsseldorf-Kaiserswerth

Düsseldorf, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Universitätsklinik Göttingen

Göttingen, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

SLK-Kliniken Heilbronn

Heilbronn, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Universitätsklinik der Johannes-Gutenberg Universität Mainz

Mainz, Germany

Diakonie Klinikum Schwäbisch Hall

Schwäbisch Hall, Germany

Christliches Klinikum Unna Mitte

Unna, Germany

Helios Dr. Horst Schmidt Kliniken Wiesbaden

Wiesbaden, Germany

Policlinico St. Orsola Malpighi

Bologna, Italy

ASST Spedali Civili di Brescia

Brescia, Italy

ASST Lecco - Ospedale A. Manzoni

Lecco, Italy

IRCCS Istituto nazionale dei Tumori

Milan, Italy

AOU Cagliari

Monserrato, Italy

Istituto Oncologico Veneto (IOV)

Padova, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Azienda USL IRCCS Di Reggio Emilia

Reggio Emilia, Italy

AO Ordine Mauriziano

Torino, Italy

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

Torino, Italy

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Virgen de las Nieves

Granada, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

CIOCC Clara Campal

Madrid, Spain

H. Althaia Manresa

Manresa, Spain

H.U. Virgen de la Macarena

Seville, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitario Sant Joan de Reus

Tarragona, Spain

Hospital General Universitario de Valencia

Valencia, Spain

Hospital La Fe

Valencia, Spain

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NCT05460000

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