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Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Sponsor: ARCAGY/ GINECO GROUP
Summary
SALVOVAR will be a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen.
Official title: A Pragmatic Randomized Phase III Trial to Assess the Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-07-30
Completion Date
2028-12
Last Updated
2025-12-05
Healthy Volunteers
No
Conditions
Interventions
Carboplatin
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy
Paclitaxel
Patients will be randomized 1:1: * Experimental arm: Densification of the chemotherapy administration dose and dosing schedule of carboplatin-paclitaxel (carboplatin AUC 5 every 3 weeks on day 1 and paclitaxel 80 mg/m2 every week, on day 1, day 8, and day 15, with 3 week-cycles) for 3 cycles * Standard arm: Continuation of the same 3-weekly carboplatin-paclitaxel, as administered during the neo-adjuvant chemotherapy
Locations (72)
ICO Paul Papin
Angers, France
CH d'Avignon
Avignon, France
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, France
Hôpital de la Côte Basque
Bayonne, France
CHRU Besançon - Hôpital Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, France
CHU de BREST - Hôpital Cavale Blanche
Brest, France
Centre François Baclesse
Caen, France
Centre d'Oncologie et de Radiothérapie 37 (ROC37)
Chambray-lès-Tours, France
Centre Hospitalier de Cholet
Cholet, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France
Centre Hospitalier Intercommunal de Créteil
Créteil, France
Centre Georges François Leclerc
Dijon, France
CHU de Dijon
Dijon, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, France
Hôpital André Mignot
Le Chesnay, France
CHRU de Lille
Lille, France
Centre Oscar Lambret
Lille, France
CHU de Limoges - Hôpital Dupuytren
Limoges, France
Hôpital de la Croix Rousse
Lyon, France
Centre Léon Bérard
Lyon, France
Hôpital Privé Jean Mermoz
Lyon, France
Hôpital de la Timone
Marseille, France
CHRU de Montpellier - Hôpital Saint-Eloi
Montpellier, France
ICM Val d'Aurelle
Montpellier, France
Centre Azuréen de Cancérologie
Mougins, France
Hôpital Privé du Confluent
Nantes, France
Centre Antoine Lacassagne
Nice, France
Institut de Cancérologie du Gard - CHU de Nîmes
Nîmes, France
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, France
Hôpital Cochin
Paris, France
Hôpital Européen George Pompidou
Paris, France
Institut Curie
Paris, France
Centre Hospitalier Général de Pau
Pau, France
HCL - Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Hôpital de Poissy-Saint-Germain-en-Laye
Poissy, France
Institut Jean Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
Hôpital Privé de la Loire
Saint-Etienne, France
Institut de Cancérologie de l'Ouest - ICO
Saint-Herblain, France
CHU Saint-Etienne - Pôle de Cancérologie
Saint-Priest-en-Jarez, France
ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, France
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, France
Hôpital Foch
Suresnes, France
Hôpitaux du Léman - site Thonon-les-Bains
Thonon-les-Bains, France
Oncopole Claudius Régaud - IUCT Oncopole
Toulouse, France
Clinique Pasteur
Toulouse, France
Centre Hospitalier de Valence
Valence, France
Gustave Roussy
Villejuif, France
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Alessandria, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, Italy
Careggi University Hospital
Florence, Italy
Alessandro Manzoni Hospital
Lecco, Italy
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy
Azienda Ulss 3 Serenissima
Venice, Italy
The University of Tokyo Hospital
Bunkyō City, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Saitama Medical University International Medical Center
Hidaka, Japan
Hirosaki University Hospital
Hirosaki, Japan
The Jikei University Kashiwa Hospital
Kashiwa, Japan
St. Marianna University Hospital
Kawasaki, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Japan
Kurume University Hospital
Kurume, Japan
Nagoya University Hospital
Nagoya, Japan
Kindai University Hospital
Sayama, Japan
Tohoku University Hospital
Sendai, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan
The Cancer Institute Hospital Of JFCR
Tokyo, Japan
The Jikei University Daisan Hospital
Tokyo, Japan
The Jikei University Hospital
Tokyo, Japan
The Jikei University Katsushika Medical Center
Tokyo, Japan