Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer
NCT ID: NCT02849106
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2011-05-31
2015-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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biopsy to obtain a chemogram
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Colorectal cancer with synchronous or metachronous metastases
3. Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
4. Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
5. Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
6. No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion.
7. Life expectancy \> 3 months (ECOG 0-1-2).
8. Informed and signed consent by the patient.
Exclusion Criteria
2. Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
3. Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
4. Patient already enrolled in an other clinical trial with another first line of chemotherapy.
5. Pregnant women, breastfeeding or of childbearing age not taking contraceptive
6. Persons deprived of liberty.
7. Subject unable to make follow up schedule
18 Years
ALL
No
Sponsors
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Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Pascale Mariani, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Curie
Locations
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Institut Curie
Paris, , France
Hôpital Lariboisière
Paris, , France
Countries
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Other Identifiers
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IC 2009-08
Identifier Type: -
Identifier Source: org_study_id
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