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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Hospital, Montpellier
Sponsor:
Collaborators:
National Cancer Institute, France
Direction Générale de l'Offre de Soins
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01596790
First received: May 4, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Metastatic Colorectal Cancer
Other: Blood analysis by EPISPOT and Cellsearch
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 168
Study Start Date: April 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596790

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

Locations
France
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
Investigators
Study Director: Panabieres Catherine, PhD UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01596790     History of Changes
Other Study ID Numbers: UF 8748, ID-RCB 2011-A01130-41
Study First Received: May 4, 2012
Last Updated: February 11, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplastic Cells, Circulating
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

ClinicalTrials.gov processed this record on July 26, 2014