NCT01363739

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
Last Updated

June 2, 2011

Status Verified

May 1, 2011

First QC Date

May 31, 2011

Last Update Submit

May 31, 2011

Conditions

Keywords

VEGF polymorphism Bevacizumab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Response Rate

  • Overal survival

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.-

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Polo Oncologico Azienda Ospedaliero, Universitaria Pisana

Pisa, Pisa, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

April 1, 2009

Last Updated

June 2, 2011

Record last verified: 2011-05

Locations