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Can genes predict colorectal cancer drug success?

NCT ID NCT01822444

Knowledge-focused Sponsor: Cancer Trials Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 76 adults with advanced colorectal cancer to find genetic markers that might predict how well a combination of chemotherapy (FOLFOX) and the drug bevacizumab works. The goal was to understand which patients benefit most, not to test a new cure. Participants had a specific gene mutation (mutant K-ras) and received standard treatment while researchers analyzed their DNA and tumor responses.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

76 people

The number who actually took part.

Started

Nov 2012

Finished

Feb 2017

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥ 18 years of age. 2. Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum. 3. 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) 4. Naive for bvz 5. An evaluable site of disease 6. ECOG Performance status 0, 1, or 2 7. Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min 8. Adequate hematopoietic function \[white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl\] 9. 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) 10. Ability to give signed informed consent prior to any screening procedures 11. FFPE Tissue is available Exclusion Criteria: 1. Patient has received any other investigational product within 28 days of first day of study drug dosing 2. Patients having familial and/or hereditary CRC 3. CRC associated with ulcerative colitis 4. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced colorectal cancer

Contacts and locations

Locations

  • Beaumont Hospital

    Dublin, Ireland

  • Bon Secours Hospital

    Cork, Ireland

  • Cork University Hospital

    Cork, Ireland

  • Galway University Hospital

    Galway, Ireland

  • Gemeinschaftspraxis Haematologie/Onkologie

    Lebach, Germany

  • Kilnikum Ludwigsburg

    Ludwigsburg, Germany

  • Medizinische Klinik III, Universitaetsklinikum

    Aachen, Germany

  • Medizinische Klinik and Poliklinik Mainz

    Mainz, Germany

  • Onkologisches Zentrum

    Deggendorf, Germany

  • Private Practice Oncology

    Speyer, Rhineland-Palatinate, Germany

  • Sligo General Hospital

    Sligo, Ireland

  • St James Hospital

    Dublin, Ireland

  • St Vincent's University Hospital

    Dublin, D4, Ireland

  • The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital

    Dublin, Ireland

  • Univeritaetsmedizin Mannheim

    Mannheim, Germany

  • University Hospital Saarland

    Homburg, Germany

  • Waterford Regional Hospital

    Waterford, Ireland

More trials for these conditions

Other studies related to the condition(s) this trial covers.