RecruitingPhase 2NCT05183984

Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer

Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery

Sponsor

ARCAGY/ GINECO GROUP

Enrollment

390 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer

Summary

Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of niraparib (a PARP inhibitor that blocks cancer cell DNA repair) and bevacizumab (a drug that cuts off tumor blood supply) given after surgery and chemotherapy can prevent ovarian cancer from coming back in patients who had their cancer completely removed. **You may be eligible if:** - You are a woman 18 years or older - You have been newly diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer (FIGO stage IIIA–IIIC) - Your cancer was completely removed during surgery (no visible disease remaining) - Your cancer is high-grade serous, high-grade endometrioid, or another non-mucinous, non-clear cell type with a BRCA1 or BRCA2 mutation - You have started the first cycle of standard chemotherapy (carboplatin + paclitaxel) within 6 weeks of surgery - You are in good health (ECOG 0–1) and eligible for bevacizumab **You may NOT be eligible if:** - You have residual disease after surgery - Your cancer is mucinous or clear cell type (unless you have a BRCA mutation) - You have already received more than one cycle of chemotherapy - You are not eligible for bevacizumab due to medical conditions 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

DRUGChemotherapy

Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period

DRUGBevacizumab-Awwb

MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles. the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months.

DRUGNiraparib

niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years.

Locations(88)

ICO Paul Papin

Angers, France

Sainte Catherine Institut du cancer Avignon-Provence

Avignon, France

CHRU Besançon - Hôpital Jean Minjoz

Besançon, France

Clinique Tivoli-Ducos

Bordeaux, France

Institut Bergonié

Bordeaux, France

Hôpital Morvan CHRU de Brest

Brest, France

HCL - Groupe Hospitalier Est

Bron, France

Centre François Baclesse

Caen, France

Centre Hospitalier de Cholet

Cholet, France

Centre Jean Perrin

Clermont-Ferrand, France

CHU de Dijon - Bourgogne

Dijon, France

Centre Georges François Leclerc

Dijon, France

Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard

Grenoble, France

CHU Grenoble-Alpes - Site Nord (La Tronche)

La Tronche, France

Clinique Victor Hugo

Le Mans, France

Centre Oscar Lambret

Lille, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

Hôpital Privé Jean Mermoz

Lyon, France

HCL - Hôpital de la Croix Rousse

Lyon, France

Institut Paoli Calmettes

Marseille, France

Hôpital Nord Marseille

Marseille, France

Institut régional du cancer de Montpellier

Montpellier, France

CHU Montpellier - Hôpital Saint Eloi

Montpellier, France

Centre Azuréen de Cancérologie

Mougins, France

ORACLE - Centre d'Oncologie de Gentilly

Nancy, France

Hôpital Privé du Confluent

Nantes, France

Centre ONCOGARD - Institut de cancérologie du Gard

Nîmes, France

CHR Orléans

Orléans, France

Groupe Hospitalier Pitié Salpêtrière

Paris, France

Hôpital cochin

Paris, France

Hôpital Saint-Joseph

Paris, France

Institut Mutualiste Montsouris

Paris, France

Hôpital Européen Georges Pompidou

Paris, France

Groupe Hospitalier Diaconesses - Croix Saint-Simon

Paris, France

Hôpital Tenon

Paris, France

HCL - Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)

Pierre-Bénite, France

Centre CARIO - HPCA

Plérin, France

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, France

Institut Jean Godinot

Reims, France

Centre Eugène Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

ICO - Centre René Gauducheau

Saint-Herblain, France

CHU de Saint-Etienne - Pôle de Cancérologie

Saint-Priest-en-Jarez, France

ICANS - Institut de cancérologie Strasbourg Europe

Strasbourg, France

CHU de Strasbourg Hôpital de Hautepierre

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

CHU Tours - Hôpital Bretonneau

Tours, France

CH Valence

Valence, France

Gustave Roussy

Villejuif, France

Firenze-Careggi

Florence, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Istituto Europeo di Oncologia (IEO)

Milan, Italy

Ospedale San Gerardo Monza

Monza, Italy

Presidio Ospedaliero di Sondrio

Sondrio, Italy

Cancer Institute Hospital Of JFCR

Tokyo, Ariake, Koto, Japan

National Cancer Center Hospital East

Kashiwanoha, Chiba, Japan

Kurume University Hospital Clinical Research Center

Kurume, Fukuoka, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki-Pref, Japan

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Okayama University Hospital

Kita-ku, Okayama-ken, Japan

Jichi Medical UH

Shimotsuke, Tochigi, Japan

Ehime University Hospital

Ehime, Toonshi, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Saitama Medical University International Medical Center

Saitama, Japan

National University Hospital (NUH)

Singapore, Singapore

National Cancer Centre Singapore

Singapore, Singapore

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

National Cancer Center

Seoul, Gyeonggi-do, South Korea

National University Hospital

Seoul, Jongno-gu, South Korea

Severance Hospital

Seoul, Seodaemun-gu, South Korea

Asan Medical Center

Seoul, Songpa-gu, South Korea

Coruña University Hospital (CHUAC)

A Coruña, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Dexeus

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Hospital Universitario de Jerez

Jerez de la Frontera, Spain

Clínica Universidad de Navarra

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Virgen de la Victoria

Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Clinica Universidad de Navarra.

Pamplona, Spain

Complejo Hospitalario de Navarra

Pamplona, Spain

CHU de Santiago de Compostela

Santiago de Compostela, Spain

Hospital Universitari MutuaTerrassa

Terrassa, Spain

Fundación Investigación Clínico de Valencia.

Valencia, Spain

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NCT05183984

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