Titre :

Study protocol of regosarc trial: activity and safety of regorafenib in advanced soft tissue sarcoma: a multinational, randomized, placebo-controlled, phase ii trial

Auteur(s) :

Brodowicz, Thomas [Auteur]

Liegl-Atzwanger, Bernadette [Auteur]

Tresch-Bruneel, Emmanuelle [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Taieb, Sophie [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Kramar, Andrew [Auteur]
Site de Recherche Intégrée en Cancérologie [SIRIC-ONCOLille]
Gruenwald, Viktor [Auteur]
Medizinische Hochschule Hannover = Hannover Medical School [MHH]
Vanseymortier, Marie [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Clisant-Delaine, Stephanie [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Blay, Jean-Yves [Auteur]
Centre Léon Bérard [Lyon]
Le Cesne, Axel [Auteur]
Institut Gustave Roussy [IGR]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]

Titre de la revue :

BMC Cancer

Nom court de la revue :

BMC Cancer

Numéro :

15

Date de publication :

2015-03-14

ISSN :

1471-2407

Mot(s)-clé(s) en anglais :

Randomized phase II trial
Angiogenesis
Placebo-controlled trial
Progression-free survival
Sarcoma
Regorafenib
Mesh:Sarcoma/diagnosis*
Mesh:Treatment Outcome
Mesh:Sarcoma/epidemiology
Mesh:Sarcoma/drug therapy*
Mesh:France/epidemiology
Mesh:Follow-Up Studies
Mesh:Female
Mesh:Double-Blind Method
Mesh:Disease-Free Survival
Mesh:Austria/epidemiology
Mesh:Humans
Mesh:Germany/epidemiology
Mesh:Male
Mesh:Phenylurea Compounds/therapeutic use*
Mesh:Pyridines/therapeutic use*

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

BACKGROUND: Angiogenesis, among other signaling pathways, plays a key-role in sarcoma biology. Regorafenib (RE) has recently been shown to be effective in imatinib and sunitinib-refractory GIST in a phase III trial. METHODS: ...
Lire la suite >BACKGROUND: Angiogenesis, among other signaling pathways, plays a key-role in sarcoma biology. Regorafenib (RE) has recently been shown to be effective in imatinib and sunitinib-refractory GIST in a phase III trial. METHODS: We are conducting an international trial (France, Austria and Germany) consisting in 4 parallel double-blind placebo-controlled randomized (1/1) phase II trials to assess the activity and safety of RE in doxorubicin-refractory STS (ClinicalTrials.gov: NCT01900743). Each phase II trial is dedicated to one of the 4 following histological subgroups: liposarcoma, leiomyosarcoma, synovial sarcoma and other sarcoma. Within each randomized trial the following stratification factors will be applied: countries and prior exposure to pazopanib. Key-eligibility criteria are: measurable disease, age ≥18, not > 3 previous systemic treatment lines for metastatic disease, metastatic disease not amenable to surgical resection. The primary endpoint is progression-free survival (PFS) according to central radiological review. Secondary endpoints are: Toxicity (NCI-CTC AE V4.0); time to progression; Growth modulation index in pts receiving RE after randomization; 3 and 6 months PFS-Rates, best response rate and overall survival. Each phase II trial will be separately analyzed. In 3 trials, statistical assumptions are: PFS0 = 1.6 & PFS1 = 4.6 months; 1-sided α = 0.1; β = 0.05 with a total sample size of 192 pts. To take into account the rarity of synovial sarcoma, the statistical assumptions are: PFS0 = 1.6 & PFS1 = 4.6 months; 1-sided α = 0.1; β = 0.2 Tumor assessment is done monthly during the 4 first months, and every 3 months thereafter. After central radiological confirmation of tumor progression, an optional open-label option is offered to eligible patients. CONCLUSIONS: The design of this trial allows an assessment of regorafenib activity over placebo in four sarcoma strata and might provide evidence for launching a phase III trial. This study includes both integrative and exploratory translational research program. The study is enrolling since June 2013 (TRIAL REGISTRATION NUMBER: EudraCT N°: 2012-005743-24, on the 15(th) February 2012).Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

CHU Lille
Université de Lille

Collections :

• Autres travaux scientifiques

Date de dépôt :

2019-12-09T18:15:16Z
2020-04-07T16:59:50Z