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Brief Title: ANGIOPREDICT. ICORG 12-16, V3
Official Title: 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 ID: NCT01822444
Brief Summary: Primary Objective: The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC). Secondary Objective: 1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and 2. To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.
Detailed Description: 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).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Private Practice Oncology, Speyer, Rhineland-Palatinate, Germany
Medizinische Klinik III, Universitaetsklinikum, Aachen, , Germany
Onkologisches Zentrum, Deggendorf, , Germany
University Hospital Saarland, Homburg, , Germany
Gemeinschaftspraxis Haematologie/Onkologie, Lebach, , Germany
Kilnikum Ludwigsburg, Ludwigsburg, , Germany
Medizinische Klinik and Poliklinik Mainz, Mainz, , Germany
Univeritaetsmedizin Mannheim, Mannheim, , Germany
Bon Secours Hospital, Cork, , Ireland
Cork University Hospital, Cork, , Ireland
St Vincent's University Hospital, Dublin, , Ireland
Beaumont Hospital, Dublin, , Ireland
St James Hospital, Dublin, , Ireland
The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital, Dublin, , Ireland
Galway University Hospital, Galway, , Ireland
Sligo General Hospital, Sligo, , Ireland
Waterford Regional Hospital, Waterford, , Ireland