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

Colorectal Cancer Clinical Trial

— CULTURE3D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849106
• Other study ID #: IC 2009-08
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: April 4, 2018
• Start date: May 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2018
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Lariboisière	Paris
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	time to obtain chemogram		through study completion, an average of 1 year