Metastatic Colorectal CancerPROVETTANCT01363739
Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab
An observational study of Metastatic Colorectal Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 265 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment
Who may be able to join
- 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.-
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Polo Oncologico Azienda Ospedaliero, Universitaria Pisana
Pisa, Pisa, 56126
Fotios Loupakis, MD, 050992466 ext. +39, fotiosloupakis@gmail.com
Alfredo Falcone, MD
About this study
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
-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.
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- VEGF polymorphism Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363739
- Sponsor's protocol ID
- 3108
- Acronym
- PROVETTA
- Status last verified
- May 2011
- First submitted
- 31 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01363739
- Acronym / sponsor ID
- PROVETTA / 3108
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- VEGF polymorphism Bevacizumab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- Apr 2009
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment
Key inclusion criteria (5 listed)
- 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.-
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Response Rate
Overal survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Polo Oncologico Azienda Ospedaliero, Universitaria Pisana
Pisa, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.