Colorectal Cancer
Conditions
Keywords
3D culture, chemogram, FOLFOX, FOLFIRI
Brief summary
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
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.
Interventions
PROCEDUREbiopsy 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
Sponsors
Institut Curie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years old or more 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
1. Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of interpretable chemogram | through study completion, an average of 1 year | In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement. | 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. | 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 | through study completion, an average of 1 year | — |
Countries
France
Outcome results
None listed