Colorectal Cancer, Metastasis
Conditions
Brief summary
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.
Interventions
BIOLOGICALBevacizumab + 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.
Sponsors
UMR-S Inserm 1036
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line. * At least one extra-osseous, non-irradiated, measurable site (\>= 10 mm with spiral CT). * No prior radiotherapy treatment unless treatment is over for at least 4 weeks. * Adult patients. * PS \<= 2. * Life expectancy greater than 3 months. * Mandatory affiliation with a healthy security insurance. * Signed written informed consent.
Exclusion criteria
* Prior chemotherapy for the metastatic cancer. * Prior bevacizumab treatment. * Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease. * Patient deprived of freedom. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate to treatment | Up to 1 year at most | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of vascular toxicities | Up to 1 year | Assess the link between vascular toxicities and VE-cadherin rate. These toxicities will be assessed during the follow-up of patients. |
| Clinical benefit | At progression or up to 1 year at most | The clinical benefit is based on complete response, partial response or stable disease. This outcome measure will be correlated to biological factors. |
| Evaluation of progression-free survival | From the beginning of treatment to progression, death or last available information | This outcome measure will be correlated to biological factors. |
| Evaluation of overall survival | From the beginning of treatment to death or last available information | This outcome measure will be correlated to biological factors. |
| Evaluation of tumoral markers | At progression with bevacizumab or up to 1 year of follow-up at most | Evaluation of ACE and Ca19-9 |
Countries
France
Outcome results
None listed