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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
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.
SALVOVAR is 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 same standard regimen as given during neo-adjuvant period. The randomization will be stratified on the main clinical prognostic factors assumed to impact the efficacy of the assessed arms and the overall survival: 1. Bevacizumab: planned administration: Yes, vs No 2. BRCA mutation: planned administration: Yes, vs No/Unknown 3. KELIMTM strate within unfavorable KELIM subgroup: very unfavorable \< 0.7, vs moderately unfavorable \[0.7-1.0\[ The trial will be pragmatic, as it aims at confirming the superiority of the adjusted chemotherapy compared to the continuation of the standard chemotherapy in routine clinical practice, in a population of ovarian cancer patients close to the real-life clinical activity with few selection criteria.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
July 30, 2024
Primary Completion Date
June 1, 2027
Completion Date
December 1, 2028
Last Updated
December 5, 2025
250
ESTIMATED participants
Carboplatin
DRUG
Paclitaxel
DRUG
Lead Sponsor
ARCAGY/ GINECO GROUP
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
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