ANGIOPREDICT. ICORG 12-16, V3
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
1 other identifier
observational
76
2 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2012
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedApril 13, 2026
April 1, 2026
4.3 years
February 25, 2013
April 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Validation of identified biomarkers
4 years
Study Arms (1)
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
Interventions
Eligibility Criteria
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.
You may qualify if:
- Patients ≥ 18 years of age.
- Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- Planned combination bevacizumab (bvz) treatment with either:
- leucovorin, fluorouracil and oxaliplatin (FOLFOX)
- capecitabine and oxaliplatin (XELOX)
- leucovorin, fluorouracil and irinotecan (FOLFIRI)
- capecitabine and irinotecan (XELIRI)
- Naive for bvz
- An evaluable site of disease
- ECOG Performance status 0, 1, or 2
- Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min
- Adequate hematopoietic function \[white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl\]
- Adequate end organ function, defined as the following: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 3.0 x ULN (in case of liver metastases SGOT and SGPT \< 5.0 x ULN)
- Ability to give signed informed consent prior to any screening procedures
- FFPE Tissue is available
You may not qualify if:
- Patient has received any other investigational product within 28 days of first day of study drug dosing
- Patients having familial and/or hereditary CRC
- CRC associated with ulcerative colitis
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
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, D4, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
April 2, 2013
Study Start
November 1, 2012
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
April 13, 2026
Record last verified: 2026-04