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

PHASE3RecruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

July 30, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2028

Conditions
Ovarian Cancer
Interventions
DRUG

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"

DRUG

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"

Trial Locations (68)

14076

NOT_YET_RECRUITING

Centre François Baclesse, Caen

15121

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria, Alessandria

20141

NOT_YET_RECRUITING

Istituto Europeo Di Oncologia S.r.l., Milan

21079

NOT_YET_RECRUITING

Centre Georges François Leclerc, Dijon

RECRUITING

CHU de Dijon, Dijon

22190

NOT_YET_RECRUITING

Centre CARIO - HPCA, Plérin

23900

NOT_YET_RECRUITING

Alessandro Manzoni Hospital, Lecco

25030

RECRUITING

CHRU Besançon - Hôpital Jean Minjoz, Besançon

26953

NOT_YET_RECRUITING

Centre Hospitalier de Valence, Valence

29200

RECRUITING

CHU de BREST - Hôpital Cavale Blanche, Brest

30029

NOT_YET_RECRUITING

Institut de Cancérologie du Gard - CHU de Nîmes, Nîmes

30174

NOT_YET_RECRUITING

Azienda Ulss 3 Serenissima, Venice

31059

NOT_YET_RECRUITING

Oncopole Claudius Régaud - IUCT Oncopole, Toulouse

31300

RECRUITING

Clinique Pasteur, Toulouse

33076

RECRUITING

Institut Bergonié, Bordeaux

34059

NOT_YET_RECRUITING

CHRU de Montpellier - Hôpital Saint-Eloi, Montpellier

34298

NOT_YET_RECRUITING

ICM Val d'Aurelle, Montpellier

35042

NOT_YET_RECRUITING

Centre Eugène Marquis, Rennes

37170

RECRUITING

Centre d'Oncologie et de Radiothérapie 37 (ROC37), Chambray-lès-Tours

38028

NOT_YET_RECRUITING

Groupe Hospitalier Mutualiste de Grenoble, Grenoble

40138

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico, Bologna

42100

NOT_YET_RECRUITING

Hôpital Privé de la Loire, Saint-Etienne

42271

NOT_YET_RECRUITING

CHU Saint-Etienne - Pôle de Cancérologie, Saint-Priest-en-Jarez

44202

RECRUITING

Hôpital Privé du Confluent, Nantes

44805

NOT_YET_RECRUITING

Institut de Cancérologie de l'Ouest - ICO, Saint-Herblain

49055

RECRUITING

ICO Paul Papin, Angers

49300

NOT_YET_RECRUITING

Centre Hospitalier de Cholet, Cholet

50134

NOT_YET_RECRUITING

Careggi University Hospital, Florence

59000

NOT_YET_RECRUITING

CHRU de Lille, Lille

59020

NOT_YET_RECRUITING

Centre Oscar Lambret, Lille

63011

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

64046

NOT_YET_RECRUITING

Centre Hospitalier Général de Pau, Pau

64100

RECRUITING

Hôpital de la Côte Basque, Bayonne

67033

RECRUITING

ICANS - Institut de cancérologie Strasbourg Europe, Strasbourg

69373

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

NOT_YET_RECRUITING

Hôpital Privé Jean Mermoz, Lyon

69495

RECRUITING

HCL - Centre Hospitalier Lyon Sud, Pierre-Bénite

74130

NOT_YET_RECRUITING

Centre Hospitalier Alpes Leman, Contamine-sur-Arve

74203

NOT_YET_RECRUITING

Hôpitaux du Léman - site Thonon-les-Bains, Thonon-les-Bains

75012

NOT_YET_RECRUITING

Groupe Hospitalier Diaconesses - Croix Saint-Simon, Paris

75014

NOT_YET_RECRUITING

Hôpital Cochin, Paris

75248

NOT_YET_RECRUITING

Institut Curie, Paris

78157

NOT_YET_RECRUITING

Hôpital André Mignot, Le Chesnay

78303

NOT_YET_RECRUITING

Hôpital de Poissy-Saint-Germain-en-Laye, Poissy

84902

NOT_YET_RECRUITING

CH d'Avignon, Avignon

84918

RECRUITING

Sainte-Catherine Institut du Cancer Avignon-Provence, Avignon

87042

NOT_YET_RECRUITING

CHU de Limoges - Hôpital Dupuytren, Limoges

92151

NOT_YET_RECRUITING

Hôpital Foch, Suresnes

94010

NOT_YET_RECRUITING

Centre Hospitalier Intercommunal de Créteil, Créteil

94805

NOT_YET_RECRUITING

Gustave Roussy, Villejuif

06250

NOT_YET_RECRUITING

Centre Azuréen de Cancérologie, Mougins

06189

RECRUITING

Centre Antoine Lacassagne, Nice

Unknown

NOT_YET_RECRUITING

The University of Tokyo Hospital, Bunkyō City

NOT_YET_RECRUITING

Fukushima Medical University Hospital, Fukushima

RECRUITING

Saitama Medical University International Medical Center, Hidaka

NOT_YET_RECRUITING

Hirosaki University Hospital, Hirosaki

NOT_YET_RECRUITING

The Jikei University Kashiwa Hospital, Kashiwa

NOT_YET_RECRUITING

St. Marianna University Hospital, Kawasaki

NOT_YET_RECRUITING

Dokkyo Medical University Saitama Medical Center, Koshigaya

NOT_YET_RECRUITING

Kurume University Hospital, Kurume

NOT_YET_RECRUITING

Nagoya University Hospital, Nagoya

NOT_YET_RECRUITING

Kindai University Hospital, Sayama

NOT_YET_RECRUITING

Tohoku University Hospital, Sendai

NOT_YET_RECRUITING

Osaka Medical and Pharmaceutical University Hospital, Takatsuki

NOT_YET_RECRUITING

The Cancer Institute Hospital Of JFCR, Tokyo

NOT_YET_RECRUITING

The Jikei University Daisan Hospital, Tokyo

NOT_YET_RECRUITING

The Jikei University Hospital, Tokyo

NOT_YET_RECRUITING

The Jikei University Katsushika Medical Center, Tokyo

All Listed Sponsors
collaborator

Horizon 2020 - European Commission

OTHER

lead

ARCAGY/ GINECO GROUP

OTHER