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

NCT02849106 | Completed

• 1 other identifier: IC 2009-08
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Cancer

Keywords

3D culture; chemogram; FOLFOX; FOLFIRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.

  through study completion, an average of 1 year

• Chemosensitivity evaluated on 3D culture.

  through study completion, an average of 1 year

• time to obtain chemogram

  through study completion, an average of 1 year

Study Arms (1)

biopsy to obtain a chemogram

EXPERIMENTAL

Procedure: biopsy to obtain a chemogram

Interventions

biopsy to obtain a chemogram PROCEDURE

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

biopsy to obtain a chemogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years old or more
• Colorectal cancer with synchronous or metachronous metastases
• Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy
• Measurable metastatic disease (echography, CT and/or MRI, PET-FDG)
• Indication for treatment with a combination including FOLFOX/FOLFIRI associated to an anti VEGF drug (Avastin)
• Life expectancy \> 3 months (ECOG 0-1-2).
• Informed and signed consent by the patient.

You may not qualify if:

• Elevation of Carcinoembryonic antigen (CEA) without measurable metastatic disease
• Medical contraindication to chemotherapy or biotherapy as FOLFOX/FOLFIRI or Avastin.
• Treatment with FOLFOX/FOLFIRI and biotherapy anti-EGFR (epidermal growth factor receptor)(Erbitux) planned
• Patient already enrolled in an other clinical trial with another first line of chemotherapy.
• Pregnant women, breastfeeding or of childbearing age not taking contraceptive
• Persons deprived of liberty.
• Subject unable to make follow up schedule

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (2)

Institut Curie

Paris, 75005, France

Location

Hôpital Lariboisière

Paris, 75475, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Pascale Mariani, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 29, 2016
• Study Start: May 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)