Spots Global Cancer Trial Database for Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
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Trial Identification
Brief Title: Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
Official Title: 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
Study ID: NCT05183984
Conditions
Study Description
Brief 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.
Detailed Description: Phase II, randomized, open label, multicenterstudy. Randomization on a 1:1 ratio, stratification performed according to: BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
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
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
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
Institut Claudius Regaud, Toulouse, , France
CHU Tours - Hôpital Bretonneau, Tours, , France
Gustave Roussy, Villejuif, , France
Saitama Medical University International Medical Center, Saitama, , Japan
Contact Details
Name: Gilles FREYER, Pr
Affiliation: HCL - Centre Hospitalier Lyon Sud
Role: PRINCIPAL_INVESTIGATOR
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