Spots Global Cancer Trial Database for Regorafenib in Relapsed Glioblastoma
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Trial Identification
Brief Title: Regorafenib in Relapsed Glioblastoma
Official Title: Regorafenib in Relapsed Glioblastoma REGOMA Study Randomized, Controlled Open-label Phase II Clinical Trial
Study ID: NCT02926222
Conditions
Study Description
Brief Summary: This study aims to evaluate the role of Regorafenib in prolonging the overall survival of glioblastoma multiforme patients who progressed after surgery and Stupp regimen with or without bevacizumab.
Detailed Description: The primary aim of the study is to evaluate the overall survival (OS) in the intention to treat (ITT) population. Secondary aims are to evaluate the progression free survival (PFS), safety, objective response rate (ORR), disease control rate (DCR) in the ITT population, and the evaluation of quality of life (QoL). Additional exploratory objectives include the analysis of antiangiogenic and metabolic biomarkers in tissue at first and second surgery (if performed) by the evaluation of certain metabolic features of tumors that could be involved in tumor responses to antiangiogenic drugs.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
IRCCS "Saverio de Bellis, Castellana Grotte, BA, Italy
Ospedale di Bellaria, Bologna, BO, Italy
Azienda Ospedaliera "G.Rummo", Benevento, BR, Italy
istituto Scientifico Romagnolo per lo Studio e Cura dei Tumori, Cesena, FC, Italy
Istituto Neurologico C. Besta IRCCS, Milano, MI, Italy
Istituto Oncologico Veneto IRCCS, Oncologia Medica 1, Padova, PD, Italy
Ospedale Santa Chiara, Pisa, PI, Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia, Udine, UD, Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza, Torino, , Italy
Contact Details
Name: Vittorina Zagonel, MD
Affiliation: Istituto Oncologico Veneto IRCCS
Role: PRINCIPAL_INVESTIGATOR
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