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

NCT01596790 | Completed

• 2 other identifiers: 8748ID-RCB 2011-A01130-41
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Bevacizumab; Circulating tumor cells; Treatment efficiency

Outcome Measures

Primary Outcomes (1)

• Predictive value of the CTC on the Progression Free Survival

  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.

  Duration study 3 years

Secondary Outcomes (4)

• Prognostic value of the CTC detected by EPISPOT

  Duration study 3 years

• Predictive value of the CTC on the overall survival

  Duration study 3 years

• VEGF expressions by the CTC

  Duration study 3 years

• Comparison of the results with the CellSearch system vs EPISPOT

  Duration study 3 years

Study Arms (1)

CTC assay

OTHER

Detection \& characterization of viable CTC in the peripheral blood.

Other: Blood analysis by EPISPOT and Cellsearch

Interventions

Blood analysis by EPISPOT and Cellsearch OTHER

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.

CTC assay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• nd 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• National Cancer Institute, France: collaborator
• Direction Générale de l'Offre de Soins: collaborator
• Roche Pharma AG: collaborator

Study Sites (1)

Medical Oncology, CHU St Eloi

Montpellier, 34090, France

Location

Related Publications (1)

• Cayrefourcq L, Thomas F, Mazard T, Assenat E, Assou S, Alix-Panabieres C. Selective treatment pressure in colon cancer drives the molecular profile of resistant circulating tumor cell clones. Mol Cancer. 2021 Feb 8;20(1):30. doi: 10.1186/s12943-021-01326-6.

  PMID: 33557844 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Panabieres Catherine, PhD

  UH Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 11, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

FR (1)