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

May 31, 2011 updated by: Azienda Ospedaliero, Universitaria Pisana

Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients

-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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • Recruiting
        • Polo Oncologico Azienda Ospedaliero, Universitaria Pisana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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