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Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy
Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.
Patients will be randomized 1:1 using a centralized randomization software, assuring concealment, with a minimization program controlling for the following factors: * Histological subgroups: leiomyosarcoma versus synovial sarcoma versus other histological subtype * Response to doxorubicin-based chemotherapy: partial response versus stable disease * Centers The treatment will be administrated as long as it appears beneficial. Evaluations will be made every 8 weeks until 6 months and then every 3 months
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
CHRU Besançon
Besançon, France
Institut Bergonié
Bordeaux, France
Centre François Baclesse
Caen, France
Centre Georges-François LECLERC
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Hôpital La Timone
Marseille, France
Institut Paoli-Calmettes
Marseille, France
Institut régional du Cancer de Montpellier
Montpellier, France
Centre René Gauducheau
Nantes, France
Start Date
May 15, 2019
Primary Completion Date
March 15, 2024
Completion Date
September 26, 2024
Last Updated
March 18, 2026
127
ACTUAL participants
Regorafenib
DRUG
Placebo
DRUG
Lead Sponsor
Centre Oscar Lambret
NCT06797999
NCT03138161
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04200443