Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer (CULTURE3D)
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|ClinicalTrials.gov Identifier: NCT02849106|
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: biopsy to obtain a chemogram||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
|Experimental: biopsy to obtain a chemogram||
Procedure: biopsy to obtain a chemogram
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
- Number of interpretable chemogram [ Time Frame: through study completion, an average of 1 year ]In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.
- Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement. [ Time Frame: through study completion, an average of 1 year ]Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.
- Chemosensitivity evaluated on 3D culture. [ Time Frame: through study completion, an average of 1 year ]on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.
- time to obtain chemogram [ Time Frame: through study completion, an average of 1 year ]
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): NCT02849106
|Paris, France, 75005|
|Paris, France, 75475|
|Principal Investigator:||Pascale Mariani, MD||Institut Curie|