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

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ClinicalTrials.gov Identifier: NCT01596790
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : May 11, 2012
Last Update Posted : December 4, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Other: Blood analysis by EPISPOT and Cellsearch Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
CTC assay
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.

Outcome Measures

Primary Outcome Measures :
  1. Predictive value of the CTC on the Progression Free Survival [ Time Frame: 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 :
  1. Prognostic value of the CTC detected by EPISPOT [ Time Frame: 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.

  2. Predictive value of the CTC on the overall survival [ Time Frame: Duration study 3 years ]
    The overall survival will be defined as the time between the beginning of the chemotherapy and death.

  3. VEGF expressions by the CTC [ Time Frame: Duration study 3 years ]
    To evaluate the VEGF expression by the CTC with both technologies, the EPISPOT and the CellSearch®.

  4. Comparison of the results with the CellSearch system vs EPISPOT [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596790

Contact: Panabieres Catherine, PHD 33 4 67 33 05 05 c-panabieres@chu.montpellier.fr

Medical Oncology, CHU St Eloi Recruiting
Montpellier, France, 34090
Contact: YCHOU Marc, MD    +33 4 67 33 01 37    m-ychou@chu-montpellier.fr   
Contact: PANABIERES Catherine, PhD    + 33 4 67 33 05 05    c-panabieres@chu-montpellier.fr   
Principal Investigator: Marc YCHOU, MD         
Sub-Investigator: Eric ASSENAT, MD         
Sponsors and Collaborators
University Hospital, Montpellier
National Cancer Institute, France
Direction Générale de l'Offre de Soins
Roche Pharma AG
Study Director: Panabieres Catherine, PhD UH Montpellier
More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01596790     History of Changes
Other Study ID Numbers: UF 8748
ID-RCB 2011-A01130-41 ( Other Identifier: Afssaps )
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Montpellier:
Circulating tumor cells
Treatment efficiency

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes