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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
Information provided by:
Azienda Ospedaliero, Universitaria Pisana Identifier:
First received: May 31, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
-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.

Metastatic Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients

Resource links provided by NLM:

Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 265
Study Start Date: April 2009

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment

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:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01363739

Polo Oncologico Azienda Ospedaliero, Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Fotios Loupakis, MD    050992466 ext +39   
Principal Investigator: Alfredo Falcone, MD         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
  More Information

Responsible Party: Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana Identifier: NCT01363739     History of Changes
Other Study ID Numbers: 3108
Study First Received: May 31, 2011
Last Updated: May 31, 2011

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
VEGF polymorphism Bevacizumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on September 21, 2017