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NCT Number: NCT02849106

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lariboisière, Paris, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Acronym: CULTURE3D

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 29, 2016
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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