Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
Assessment by EPISPOT of Circulating Tumor Cells as an Early Predictive Marker of Response to Chemotherapy and Targeted Therapy in Patients With Metastatic Colorectal Cancer in First Line of Treatment
In the aim to study a homogeneous cohort of patients, the investigators will only recruit
patients in first line of treatment and treated by 5-FU (IV), IRINOTECAN et BEVACIZUMAB
combination.
Inclusion Criteria:
- Age > 18 years
- Colon or rectum adenocarcinoma (based on the histology)
- Visceral metastases (synchronous and/or metachronous)
- Metastatic disease measurable with the RECIST 1.1 criteria
- WHO performance status 0, 1 or 2
- Life expectancy>3 months when starting the treatment
- Chemotherapy in metastatic 1rst line combining a protocol of conventional
chemotherapy combining 5-FU and IRINOTECAN (FOLFIRI, XELIRI) associated with
bevacizumab
- Follow-up of at least one year
- Collection of the written consent
- Social security affiliation
Exclusion Criteria:
- 2nd line chemotherapy and beyond
- History of other cancers considered not cured
- Active and progressive infection or other serious disease that may not allow the
patient to receive the treatment
- refusal to participate
- Patient unable to express his consent
- Pregnant women
- Patient unable to be followed-up for at least one year
- Current participation to another clinical trial
- Patients under guardianship
- Vulnerable people protected by the law
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Predictive value of the CTC on the Progression Free Survival
Outcome Description:
The primary outcome aims to evaluate the predictive value of the early progression of the CTC performed with the EPISPOT assay on the PFS in a cohort of patients treated with 5-FU, IRNOTECAN et AVASTIN (FOLFIRI or XELIRI-AVASTIN) in 1rst line of metastatic colorectal cancer. The progression disease is assessed based on imagery techniques.
Outcome Time Frame:
Duration study 3 years
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
UF 8748
NCT ID:
NCT01596790
Start Date:
April 2012
Completion Date:
April 2016
Related Keywords:
- Metastatic Colorectal Cancer
- Bevacizumab
- Circulating tumor cells
- Treatment efficiency
- Colorectal Neoplasms
- Neoplastic Cells, Circulating
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