Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT01363739
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

Brief Summary

-1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of metastatic colorectal cancer patients. The present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Status Verified: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Histologically confirmed colorectal adenocarcinoma;
• Measurable metastatic disease according to RECIST criteria;
• Patients receiving BV plus FOLFIRI as first-line treatment;
• Written informed consent;
• Availability of blood samples for genetic analysis.-

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival		Progression free survival (PFS) is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment

Secondary Outcome Measures

Name	Time	Method
Response Rate		Response Rate (RR) is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST)
Overal survival		Overall survival (OS) is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point

Trial Locations

Locations (1)

Polo Oncologico Azienda Ospedaliero, Universitaria Pisana; 🇮🇹 Pisa, Italy