Spots Global Cancer Trial Database for A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC
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Trial Identification
Brief Title: A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC
Official Title: A Multinational, Randomized, Phase III Study of XELIRI With/Without Bevacizumab Versus FOLFIRI With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer
Study ID: NCT01996306
Study Description
Brief Summary: The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.
Detailed Description: Primary endpoint: Overall survival (OS), Secondary endpoints: Progression-free survival (PFS), Time to treatment failure (TTF), Overall response rate (ORR),Disease Control Rate (DCR), Relative dose intensity, Safety, and Correlation between UGT1A1 genotype and Safety.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NPO Epidemiological and Clinical Research Information Network (ECRIN), Kyoto, , Japan
Contact Details
Name: Kei Muro, MD
Affiliation: Aichi Cancer Center Hospital, Japan
Role: PRINCIPAL_INVESTIGATOR
Name: Tae Won Kim, MD, PhD
Affiliation: ASAN Medical center, South Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Young Suk Park, MD, PhD
Affiliation: Samsung Medical Center, South Korea
Role: PRINCIPAL_INVESTIGATOR
Name: Ruihua Xu, MD, PhD
Affiliation: Sun Yat-Sen University Cancer Center, China
Role: PRINCIPAL_INVESTIGATOR
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