Colorectal CancerNCT01726309
Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4
An observational study of Colorectal Cancer and Non-Small Cell Lung Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.
Trial summary
Primary Objective: Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Non-Small Cell Lung Cancer
- How many people
- 161 participants
- Where
- 10 sitesIreland
- Study dates
- May 2011to 11 May 2021
- 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: Patient Population: 150 Patients with histologically proven stage IV (AJCC 7th Edition) colorectal cancer (CRC) expressing wild-type KRAS or stage IV non-small cell lung cancer (NSCLC) expressing EGFR (tested by immunohistochemistry (IHC)), with no previous exposure to Cetuximab or Panitumumab, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
Who may be able to join
- Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastasectomy.
- Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested)
- Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
- Karnofsky performance status (Appendix B) score ≥60.
- Acceptable laboratory values:
- Haemoglobin ≥ 9 g/dL.
Show all 11Show fewer
- Neutrophil count ≥ 1.0 x 10^9/L.
- Platelet count ≥100 x 10^9/L.
- Serum creatinine ≤1.5 times the upper limit of normal.
- Bilirubin ≤1.5 times the upper limit of normal.
- Aspartate aminotransferase and alanine aminotransferase ≤5 times the upper limit of normal.
Who cannot join
- Aged < 18 years
- Prior exposure to Cetuximab or Panitumumab
- The CRC does not carry wild-type KRAS.
- The NSCLC stains negative for EGFR protein expression
- Second cancer diagnosis (apart from non-melanoma skin cancer)
- Known hypersensitivity to Cetuximab or Panitumumab, or murine protein.
- Known history of coronary artery disease, arrhythmias, or congestive heart failure (If the treating physician feels that a patient's coronary artery disease / arrhythmia / congestive heart failure does not place him/her at risk from treatment with an anti-EGFR antibody, the person can be included. This is a clinical decision, which has to be made by the treating physician).
- Known to be pregnant (pregnancy test is not mandatory) or breast-feeding.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Bon Secours Hospital
Cork
Cork University Hospital
Cork
St Vincent's University Hospital
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
Beaumont Hospital
Dublin
The Adelaide & Meath Hosptal, Dublin Incorporating The National Children's Hospital
Dublin
Galway University Hospital
Galway
Letterkenny General Hospital
Letterkenny, Donegal
Our Lady of Lourdes Hospital, Drogheda
Louth
Waterford Regional Hospital
Waterford
About this study
Official title: Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
Primary Objective:
Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.
Secondary Objectives:
Correlation of SNP profile with indicators of tumour response parameters, such as radiological response, duration of response, time to progression (TTP), overall survival (OS) time, incidence of non-dermatological adverse events.
Read the detailed description
Baseline assessment:
- Contact Lenses
- Medical History
- Previous chemotherapy
- Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
- Symptom Assessment (Pre-existing skin and/or eye conditions, CEA measurement (CRC only), Disease status (TNM Staging))
- Planned chemotherapy regimen
- Radiotherapy
Blood Sample: A 2ml blood sample should be collected in ethylenediamine-tetraacetic acid (EDTA) containing Vacutainer at any time before or after starting treatment. DNA will be extracted from the samples and the 11 SNPs in the region of the EGFR gene encoding domain III will be characterized.
Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks):
- Visit Number and Date
- Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
- Symptom Assessment (CEA measurement (CRC only), Disease status (TMN Staging), Skin Toxicity (CTCAE) grading)
- Current chemotherapy regimen
- Radiotherapy
- CEA measurement only for CRC (every second cycle/every 4 weeks)
Long-term follow-up (up to 5 years):
- CT restaging (TNM Staging) should be done 3 monthly for as long as the subject is receiving Cetuximab- or Panitumumab- containing regimen or if there is suspicion of disease progression.
- OS
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage IV CRC | Not described | |
| Stage IV NSCLC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region.
Using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: Throughout treatment with up to 5 years in follow up
Secondary outcomes (1)
Correlation between the SNP profile(s) and disease response
Time to progression TTP and OS over 5 years
Measured: Throughout treatment with up to 5 years in follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startMay 2011
- Primary completion11 May 2021
- Study completion11 May 2021
Why it stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726309
- Sponsor's protocol ID
- ICORG 08-40
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2012
- Last updated
- 8 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
- ClinicalTrials.gov ID
- NCT01726309
- Acronym / sponsor ID
- ICORG 08-40
- Conditions
- Colorectal Cancer, Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- May 2011 (actual)
- Primary completion
- 11 May 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 14 Nov 2012 (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:
Correlation of the skin and/or eye toxicity grade secondary to Cetuximab or Panitumumab and the SNP profile of the Epidermal Growth Factor Receptor (EGFR) domain III region.
Secondary Objectives:
Correlation of SNP profile with indicators of tumour response parameters, such as radiological response, duration of response, time to progression (TTP), overall survival (OS) time, incidence of non-dermatological adverse events.
Detailed description
Baseline assessment:
- Contact Lenses
- Medical History
- Previous chemotherapy
- Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
- Symptom Assessment (Pre-existing skin and/or eye conditions, CEA measurement (CRC only), Disease status (TNM Staging))
- Planned chemotherapy regimen
- Radiotherapy
Blood Sample: A 2ml blood sample should be collected in ethylenediamine-tetraacetic acid (EDTA) containing Vacutainer at any time before or after starting treatment. DNA will be extracted from the samples and the 11 SNPs in the region of the EGFR gene encoding domain III will be characterized.
Follow-up Assessment: with every second cycle of Cetuximab- or Panitumumab-containing regimen (CRC: every 2. Week; NSCLC: every 3-4 weeks):
- Visit Number and Date
- Vital Signs (weight, height, Karnofsky Performance status, heart rate, blood pressure)
- Symptom Assessment (CEA measurement (CRC only), Disease status (TMN Staging), Skin Toxicity (CTCAE) grading)
- Current chemotherapy regimen
- Radiotherapy
- CEA measurement only for CRC (every second cycle/every 4 weeks)
Long-term follow-up (up to 5 years):
- CT restaging (TNM Staging) should be done 3 monthly for as long as the subject is receiving Cetuximab- or Panitumumab- containing regimen or if there is suspicion of disease progression.
- OS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage IV CRC | – | – |
| Stage IV NSCLC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Population: 150 Patients with histologically proven stage IV (AJCC 7th Edition) colorectal cancer (CRC) expressing wild-type KRAS or stage IV non-small cell lung cancer (NSCLC) expressing EGFR (tested by immunohistochemistry (IHC)), with no previous exposure to Cetuximab or Panitumumab, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
Key inclusion criteria (11 listed)
- Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastasectomy.
- Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested)
- Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab).
- Karnofsky performance status (Appendix B) score ≥60.
- Acceptable laboratory values:
Key exclusion criteria (8 listed)
- Aged < 18 years
- Prior exposure to Cetuximab or Panitumumab
- The CRC does not carry wild-type KRAS.
- The NSCLC stains negative for EGFR protein expression
- Second cancer diagnosis (apart from non-melanoma skin cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region.
Time frame: Throughout treatment with up to 5 years in follow up
Using Common Terminology Criteria for Adverse Events (CTCAE) version 4
1 secondary outcome
Correlation between the SNP profile(s) and disease response
Time frame: Throughout treatment with up to 5 years in follow up
Results and safety
The study was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Non-Small Cell Lung Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.
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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ireland. 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 was stopped early (reason given: As per the HRBs new funding model, HRBs investment will not support costs associated with routine patient care or translational studies, biobanks, patient registries and questionnaires. Therefore, a decision was made to cease further study follow up.). Results are not available in the source record.
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?
Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region. (time frame: Throughout treatment with up to 5 years in follow up). 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 8 Jul 2025.