An interventional study of Bevacizumab + blood samples in Colorectal Cancer and Metastasis, sponsored by Centre Leon Berard. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-29.
Sponsored by Centre Leon Berard · Not applicable and Interventional
It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.
Biological factors will be correlated to clinical outcome measures.
100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.
Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.
Bevacizumab will be administered according to investigators appreciation.
Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Centre Leon Berard is the lead sponsor of 206 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Bevacizumab + blood samples
Bevacizumab will be administered according to investigators appreciation. Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.
Response rate to treatment
A 30% response rate (complete or partial response) to treatment is expected. The response will be assessed according to RECIST criteria. This primary outcome measure is defined by the observation of at least one objective response during the treatment. This outcome measure will be correlated to biological factors.
Time frame: Up to 1 year at most
Clinical benefit
The clinical benefit is based on complete response, partial response or stable disease. This outcome measure will be correlated to biological factors.
Time frame: At progression or up to 1 year at most
Evaluation of progression-free survival
This outcome measure will be correlated to biological factors.
Time frame: From the beginning of treatment to progression, death or last available information
Evaluation of overall survival
This outcome measure will be correlated to biological factors.
Time frame: From the beginning of treatment to death or last available information
Evaluation of tumoral markers
Evaluation of ACE and Ca19-9
Time frame: At progression with bevacizumab or up to 1 year of follow-up at most
Evaluation of vascular toxicities
Assess the link between vascular toxicities and VE-cadherin rate. These toxicities will be assessed during the follow-up of patients.
Time frame: Up to 1 year
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Centre Leon Berard