Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT
Study Design:
Type of Study: Exploratory, translational, multicenter and multinational Phase II study.
Patient Population:All patients from the intent-to-treat population with aCRC or mCRC,
(incurable with any conventional multimodality approach) and who fulfil all inclusion and
exclusion criteria.
Number of Patients: 224
Sample Type:
Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3
and 6) and at the end of treatment (month 12).
Observational
Observational Model: Cohort, Time Perspective: Prospective
Identification of biomarkers
Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.
4 years
No
Ireland: Health Information and Quality Authority
ICORG 12-16
NCT01822444
November 2012
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