NCT02849106

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2016-07-29
• Last updated: 2018-04-05

Locations

2 sites across 1 country: France