Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer (CULTURE3D)

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: biopsy to obtain a chemogram

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75475
    • Hôpital Lariboisière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of interpretable chemogram	In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.	Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.	through study completion, an average of 1 year
Chemosensitivity evaluated on 3D culture.	on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.	through study completion, an average of 1 year
time to obtain chemogram		through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Pascale Mariani, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: FOLFOX; 3D culture; chemogram; FOLFIRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IC 2009-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No