Clinical trial NCT01596790: COLOSPOT Study : Assessment by EPISPOT of Circulating Tumor Cells in Patients With Metastatic Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Colorectal Cancer
Keywords: Bevacizumab
Circulating tumor cells
Treatment efficiency
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Direction Générale de l'Offre de Soins
name: Roche Pharma AG
First posted: 2012-05-11
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Predictive value of the CTC on the Progression Free Survival
timeFrame: Duration study 3 years
Secondary outcomes:
measure: Prognostic value of the CTC detected by EPISPOT
timeFrame: Duration study 3 years
measure: Predictive value of the CTC on the overall survival
timeFrame: Duration study 3 years
measure: VEGF expressions by the CTC
timeFrame: Duration study 3 years
measure: Comparison of the results with the CellSearch system vs EPISPOT
timeFrame: Duration study 3 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Medical Oncology, CHU St Eloi
Study officials:
affiliation: UH Montpellier
name: Panabieres Catherine, PhD
role: STUDY_DIRECTOR
References:
citation: 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.