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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: biopsy to obtain a chemogram

• Registration Number: NCT02849106
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
biopsy to obtain a chemogram	biopsy to obtain a chemogram	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
time to obtain chemogram	through study completion, an average of 1 year

Trial Locations

Locations (2)

Hôpital Lariboisière; 🇫🇷 Paris, France

Institut Curie; 🇫🇷 Paris, France