Spots Global Cancer Trial Database for Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)
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Trial Identification
Brief Title: Regorafenib Assessment in Refractory Advanced Colorectal Cancer(RegARd-C)
Official Title: Regorafenib Assessment in Refractory Advanced Colorectal Cancer
Study ID: NCT01929616
Interventions
Study Description
Brief Summary: The general objectives are to evaluate activity and the safety of regorafenib in a population of patients bearing advanced, refractory colorectal cancers and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms.
Detailed Description: The primary objective is to identify in a population of patients bearing advanced, refractory colorectal cancers, those who draw no benefit from treatment with regorafenib. There is no specific hypothesis underlying sample size and the study is therefore to be seen as exploratory. Secondary objectives: * To analyze PFS and response rate (RR) in relationship with the same covariates as for OS * To assess regorafenib efficacy (OS, PFS, RR) and safety profile in this study population. * To assess the Disease control rate (DCR = Complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) * To compare the relative benefit (OS, PFS) of regorafenib according to history of treatment with bevacizumab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UZA, Antwerpen, Edegem, Belgium
Jules Bordet Institute, Brussels, , Belgium
Hopital Erasme, Brussels, , Belgium
Cliniques Universitaires Saint Luc, Brussels, , Belgium
Grand Hopital de Charleroi, Charleroi, , Belgium
UZ Ghent, Ghent, , Belgium
AZ groeninge, Kortrijk, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Clinique St Joseph, Liège, , Belgium
Centre hospitalier de Jolimont, Lobbes, , Belgium
CHU Ambroise Paré, Mons, , Belgium
Centre Hospitalier Régional de Namur, Namur, , Belgium
Clinique et Maternité Sainte Elisabeth, Namur, , Belgium
Clinique Saint Pierre, Ottignies, , Belgium
Hartziekenhuis Roeselare-Menen (HHRM), Roeselare, , Belgium
AZ Turnhout, Turnhout, , Belgium
Cliniques Universitaires UCL de Mont-Godinne, Yvoir, , Belgium
Contact Details
Name: Alain Hendlisz, MD
Affiliation: Jules Bordet Institute
Role: STUDY_CHAIR
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