ANGIOPREDICT. ICORG 12-16, V3
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01822444|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 26, 2020
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).
- To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
- To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.
|Condition or disease||Intervention/treatment|
|Advanced Colorectal Cancer||Other: Biomarker analysis|
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
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).
|Study Type :||Observational|
|Estimated Enrollment :||224 participants|
|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|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Intent-to-treat population with aCRC or mCRC
Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria
Other: Biomarker analysis
- Identification of biomarkers [ Time Frame: 4 years ]Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.
- Validation of identified biomarkers [ Time Frame: 4 years ]Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822444