Advanced Colorectal CancerNCT01822444
ANGIOPREDICT. ICORG 12-16, V3
An observational study of Advanced Colorectal Cancer, run by Cancer Trials Ireland at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Cancer
- What is being tested?
- Biomarker analysis
- How many people
- 76 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Nov 2012to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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)
Show all 15Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Ireland9 sites
Bon Secours Hospital
Cork
Cork University Hospital
Cork
St Vincent's University Hospital
Dublin, D4
Beaumont Hospital
Dublin
St James Hospital
Dublin
The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin
Galway University Hospital
Galway
Sligo General Hospital
Sligo
Waterford Regional Hospital
Waterford
Germany8 sites
Medizinische Klinik III, Universitaetsklinikum
Aachen
Onkologisches Zentrum
Deggendorf
University Hospital Saarland
Homburg
Gemeinschaftspraxis Haematologie/Onkologie
Lebach
Kilnikum Ludwigsburg
Ludwigsburg
Medizinische Klinik and Poliklinik Mainz
Mainz
Univeritaetsmedizin Mannheim
Mannheim
Private Practice Oncology
Speyer, Rhineland-Palatinate
About this study
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
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:
- 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.
Read the 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).
- Conditions
- Advanced Colorectal Cancer
- Being tested
- Biomarker analysis
- Keywords
- Colorectal Cancer, Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Locally Advanced Colorectal Cancer, Colon Cancer, Rectal Cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Validation of identified biomarkers
Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822444
- Sponsor's protocol ID
- ICORG 12-16
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2013
- Last updated
- 13 Apr 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01822444
- Acronym / sponsor ID
- ICORG 12-16
- Conditions
- Advanced Colorectal Cancer
- Keywords
- Colorectal Cancer, Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Locally Advanced Colorectal Cancer, Colon Cancer, Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Nov 2012 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intent-to-treat population with aCRC or mCRC | – | Other: Biomarker analysisAdvanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (15 listed)
- 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:
- Naive for bvz
- An evaluable site of disease
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker analysis | Other | Intent-to-treat population with aCRC or mCRC |
Primary outcome
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.
1 secondary outcome
Validation of identified biomarkers
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Colorectal Cancer, run by Cancer Trials Ireland at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Ireland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of biomarkers (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.