Single Nucleotide Polymorphism(SNP)Study. ICORG 08-40, V4

Colorectal Cancer Clinical Trial

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

Status Terminated

Clinical 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.

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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Cancer
• Colorectal Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT01726309
• Study type: Observational
• Source: Cancer Trials Ireland
• Status: Terminated
• Start date: May 2011
• Completion date: May 11, 2021