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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
biopsy to obtain a chemogram
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring 3D culture, chemogram, FOLFOX, FOLFIRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Curie
  • Hôpital Lariboisière

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

biopsy to obtain a chemogram

Arm Description

Outcomes

Primary Outcome Measures

Number of interpretable chemogram
In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.

Secondary Outcome Measures

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.
Chemosensitivity evaluated on 3D culture.
on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.
time to obtain chemogram

Full Information

First Posted
July 13, 2016
Last Updated
April 4, 2018
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02849106
Brief Title
Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer
Acronym
CULTURE3D
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
3D culture, chemogram, FOLFOX, FOLFIRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
biopsy to obtain a chemogram
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
biopsy to obtain a chemogram
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of interpretable chemogram
Description
In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement.
Description
Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.
Time Frame
through study completion, an average of 1 year
Title
Chemosensitivity evaluated on 3D culture.
Description
on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.
Time Frame
through study completion, an average of 1 year
Title
time to obtain chemogram
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) No adjuvant chemotherapy for the primitive colorectal cancer and no line of chemotherapy for metastatic disease during the year prior to inclusion. Life expectancy > 3 months (ECOG 0-1-2). Informed and signed consent by the patient. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascale Mariani, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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