Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Genetic: Gene mutations analysis and FISH

• Registration Number: NCT00491140
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

The primary objective is to identify molecular features predicting response or resistance to cetuximab

Detailed Description

Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2007-05
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-25
• Study Completion: 2008-06
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-30
• Last Update Posted: 2008-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion Criteria

• Less than 3 weeks after completion of previous radiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observation	Gene mutations analysis and FISH	Colorectal cancer patients

Primary Outcome Measures

Name	Time	Method
Association of different biomarkers with Cetuximab sensitivity	Assessment every two months

Secondary Outcome Measures

Name	Time	Method
Association of different biomarkers with time to progression and survival	At the end of the study

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy