Clinical trial · Observational
Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4
Correlation of Single Nucleotide Polymorphism (SNP) Profile of Domain III of EGFR to Skin Toxicity and Disease Response to Treatment With Erbitux Requirements
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Stage IV CRC
- label
- Stage IV NSCLC
Primary outcomes (1)
- measure
- Correlation between the type and degree of reported skin and/or eye reaction and the SNP profile of the EGFR domain III region.
- timeFrame
- Throughout treatment with up to 5 years in follow up
- description
- Using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Secondary outcomes (1)
- measure
- Correlation between the SNP profile(s) and disease response
- timeFrame
- Throughout treatment with up to 5 years in follow up
- description
- Time to progression TTP and OS over 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage IV (AJCC 7th Edition TMN Staging, Appendix C), histologically confirmed CRC with wild-type KRAS and not a candidate for metastasectomy. 2. Stage IV (AJCC 7th Edition, TMN Staging, Appendix C) NSCLC expressing EGFR (IHC tested) 3. Patients, who will receive treatment with an EGFR-antibody (Cetuximab or Panitumumab). 4. Karnofsky performance status (Appendix B) score ≥60. 5. Acceptable laboratory values: * Haemoglobin ≥ 9 g/dL. * 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. Exclusion Criteria: 1. Aged \< 18 years 2. Prior exposure to Cetuximab or Panitumumab 3. The CRC does not carry wild-type KRAS. 4. The NSCLC stains negative for EGFR protein expression 5. Second cancer diagnosis (apart from non-melanoma skin cancer) 6. Known hypersensitivity to Cetuximab or Panitumumab, or murine protein. 7. 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). 8. Known to be pregnant (pregnancy test is not mandatory) or breast-feeding.
References
Publications (0)
Data not yet available