COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer

Not Applicable

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Other: Blood analysis by EPISPOT and Cellsearch

• Registration Number: NCT01596790
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CTC assay	Blood analysis by EPISPOT and Cellsearch	Detection \& characterization of viable CTC in the peripheral blood.

Primary Outcome Measures

Name	Time	Method
Predictive value of the CTC on the Progression Free Survival	Duration study 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Predictive value of the CTC on the overall survival	Duration study 3 years	The overall survival will be defined as the time between the beginning of the chemotherapy and death.
Comparison of the results with the CellSearch system vs EPISPOT	Duration study 3 years	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.
Prognostic value of the CTC detected by EPISPOT	Duration study 3 years	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.
VEGF expressions by the CTC	Duration study 3 years	To evaluate the VEGF expression by the CTC with both technologies, the EPISPOT and the CellSearch®.

Trial Locations

Locations (1)

Medical Oncology, CHU St Eloi; 🇫🇷 Montpellier, France