Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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Prospective, open labelled, multicenter trial to evaluate the feasibility of ex vivo culture 3D (chemogram obtaining) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer.

Detailed Description
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The CULTURE 3D study is a prospective, open labelled, multicenter trial. The aim is to evaluate the feasibility of ex vivo culture 3D (chemogram) on biopsies in order to estimate the predictive value of this technique for treatment response in patients treated by two different chemotherapies (FOLFOX or FOLFIRI) for colorectal cancer. Patients will have biopsies in a metastasis or in the primitive tumor before treatment. The sample will be used for a 3D ex vivo cells culture. A chemogram will be made based on cells proliferation data (Ki67) and apoptosis (M30). Results from this chemogram will not interfere with the treatment combination choice. The treatment response will be evaluated by the RECIST assessment and will be then compared to the chemogram.

Official Title
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Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: biopsy to obtain a chemogram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years old or more Colorectal cancer with synchronous or metachronous metastases Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy Measurable metastatic disease (echography, CT and/or MRI, PET-FDG) Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin) No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion. Life expectancy > 3 months (ECOG 0-1-2). Informed and signed consent by the patient. Exclusion Criteria: Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin. Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned Patient already enrolled in an other clinical trial with another first line of chemotherapy. Pregnant women, breastfeeding or of childbearing age not taking contraceptive Persons deprived of liberty. Subject unable to make follow up schedule

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biopsy to obtain a chemogram<br> | Procedure: biopsy to obtain a chemogram<br>* All patients enrolled will have biopsies (on primary tumor or on a metastasis) before treatment in order to obtain a chemogram by ex vivo 3D culture cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of interpretable chemogram | In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement. | Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response. | through study completion, an average of 1 year | 
| Chemosensitivity evaluated on 3D culture. | on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed. | through study completion, an average of 1 year | 
| time to obtain chemogram |  | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D culture, chemogram, FOLFOX, FOLFIRI