COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
Treatment of metastatic colorectal cancer needs chemotherapy in most of the cases. During these last years, many new chemotherapies and targeted therapies have been developed improving significantly the overall survival of patients. However, the choice of the therapeutic sequences becomes difficult due to the lack of validated predictive biomarkers of their efficiency. Indeed, only the mutation of the k-ras oncogene is a predictive factor of non-efficacy of the anti-EGFR antibodies. It is thus crucial to identify new biomarkers to propose the best personalized 1rst line therapeutic sequence. One idea would be to enumerate and characterize the circulating tumor cells (CTC) which, as it has been described in a recent study realized by Cohen et al. in patients with metastatic colorectal cancer, would give us an early evaluation of the therapeutic efficiency. In this context, the investigators have developed an innovative technology, the EPISPOT assay (patent of the University Medical Center of Montpellier), that allows the detection & characterization of viable CTC in the peripheral blood. The EPISPOT technology has been already evaluated in the breast and prostate cancer. Thus, the investigators would like to perform a prospective study on a cohort of patients with metastatic colorectal cancer to confirm, with this technology, the predictive value of CTC count for the efficacy of the treatment.
Metastatic Colorectal Cancer
Other: Blood analysis by EPISPOT and Cellsearch
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||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|
- Predictive value of the CTC on the Progression Free Survival [ Time Frame: Duration study 3 years ] [ Designated as safety issue: No ]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.
- Prognostic value of the CTC detected by EPISPOT [ Time Frame: Duration study 3 years ] [ Designated as safety issue: No ]For the EPISPOT assay, 15 mL of peripheral blood will be collected on EDTA tubes. For each patient, 5 blood samples will be collected: at D0, D14, D28, D42 and D56.
- Predictive value of the CTC on the overall survival [ Time Frame: Duration study 3 years ] [ Designated as safety issue: No ]The overall survival will be defined as the time between the beginning of the chemotherapy and death.
- VEGF expressions by the CTC [ Time Frame: Duration study 3 years ] [ Designated as safety issue: No ]To evaluate the VEGF expression by the CTC with both technologies, the EPISPOT and the CellSearch®.
- Comparison of the results with the CellSearch system vs EPISPOT [ Time Frame: Duration study 3 years ] [ Designated as safety issue: No ]
For the Cellsearch assay, 10 mL of peripheral blood will be collected on specific tubes. Only 2 samples will be performed: at D0 and D28.
The Cellsearch and EPISPOT techniques will be performed in parallel and then compared.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||February 2016 (Final data collection date for primary outcome measure)|
Detection & characterization of viable CTC in the peripheral blood.
Other: Blood analysis by EPISPOT and Cellsearch
For each patient, we will perform a counting of CTC before chemotherapy and then at different time points after chemotherapy, using both technologies: EPISPOT and CellSearch®.For the EPISPOT, we will need 15 mL of peripheral blood on EDTA tubes. For each patient, five blood samples will be done: D0, D14, D28, D42 and D56. These different time points will help us to determine when the best moment is for the evaluation of the CTC with this technology.For the CellSearch®, we will need 10 mL of peripheral blood on a specific CellSave tube. Only two samples will be perform: D0 and D28 because Cohen et al. (2008) reported that the best appropriated moment to appreciate the CTC progression is between 3 and 5 weeks after the initiation of the 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596790
|Contact: Panabieres Catherine, PHD||33 4 67 33 05 email@example.com|
|Medical Oncology, CHU St Eloi||Recruiting|
|Montpellier, France, 34090|
|Contact: YCHOU Marc, MD +33 4 67 33 01 37 firstname.lastname@example.org|
|Contact: PANABIERES Catherine, PhD + 33 4 67 33 05 05 email@example.com|
|Principal Investigator: Marc YCHOU, MD|
|Sub-Investigator: Eric ASSENAT, MD|
|Study Director:||Panabieres Catherine, PhD||UH Montpellier|