Spots Global Cancer Trial Database for Phase II Study of Regorafenib as Maintenance Therapy
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Trial Identification
Brief Title: Phase II Study of Regorafenib as Maintenance Therapy
Official Title: Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy
Study ID: NCT03793361
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Chu Poitiers, Poitiers, , France
Institut Godinot, Reims, , France
Centre Eugène Marquis, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, , France
Hôpitaux universitaires de Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Nicolas PENEL, PhD
Affiliation: Centre Oscar Lambret
Role: STUDY_DIRECTOR
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