Clinical trial NCT02849106: Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer
Official title: Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: 3D culture
chemogram
FOLFOX
FOLFIRI
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 22
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of interpretable chemogram
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.
timeFrame: through study completion, an average of 1 year
measure: Chemosensitivity evaluated on 3D culture.
timeFrame: through study completion, an average of 1 year
measure: time to obtain chemogram
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hôpital Lariboisière
Study officials:
affiliation: Institut Curie
name: Pascale Mariani, MD
role: PRINCIPAL_INVESTIGATOR
References: