Predictive Response to Chemotherapy (FOLFOX or FOLFIRI) b... | NCT02849106

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

NCT02849106

Sponsor

Institut Curie

Status

Completed

Last Update Posted

Apr 5, 2018Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Colorectal Cancer

Interventions

biopsy to obtain a chemogram

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Jan 2015Actual

Completion Date

Jan 2015Actual

First Submitted Date

Jul 13, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 29, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2018

Last Update Posted Date

Apr 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
biopsy to obtain a chemogram	Experimental		Procedure: biopsy to obtain a chemogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Chemosensitivity evaluated on 3D culture.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pascale Mariani, MD	Institut Curie	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Institut Curie		Paris		75005	France
Hôpital Lariboisière

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

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Browse Branches

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