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

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ClinicalTrials.gov Identifier: NCT02849106
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: biopsy to obtain a chemogram Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) by ex Vivo Culture 3D Technique in Metastatic Colorectal Cancer: a Preliminary Study
Study Start Date : May 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of interpretable chemogram [ Time Frame: through study completion, an average of 1 year ]
    In ex vivo 3D culture from tumor biopsies, number of interpretable chemogram.


Secondary Outcome Measures :
  1. Correlation between chemogram results obtained by 3D culture and RECIST 1.1 response assessement. [ Time Frame: through study completion, an average of 1 year ]
    Number of chemogram showing the same response to treatment than patient RECIST 1.1 measured response.

  2. Chemosensitivity evaluated on 3D culture. [ Time Frame: through study completion, an average of 1 year ]
    on untreated and treated fragments : proliferating index (ki67) and apoptosis (M30) will be assessed.

  3. time to obtain chemogram [ Time Frame: through study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849106


Locations
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France
Institut Curie
Paris, France, 75005
Hôpital Lariboisière
Paris, France, 75475
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Pascale Mariani, MD Institut Curie

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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT02849106     History of Changes
Other Study ID Numbers: IC 2009-08
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Curie:
3D culture
chemogram
FOLFOX
FOLFIRI
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases