Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327093
Status:
TERMINATED
Last Update Posted:
2009-02-09
First Post:
2006-05-17
Brief Title:
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies Cetuximab and Bevacizumab in Patients With Colorectal Cancer and Liver Metastases
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Elaboration of a Model for Predicting Efficacy of Monoclonal Antibodies Cetuximab and Bevacizumab in Patients With Colorectal Cancer and Liver Metastases
Status:
TERMINATED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The scientific commitee decided to stop the inclusions and exploit the results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective This trial is elaborating a model for rapidly predicting day 21 the response to monoclonal antibodies anti-EGFR and anti-VEGF cetuximab and bevacizumab based on biological markers andor functional imaging The response to treatment is evaluated by the conventional method after 2 months Response Evaluation Criteria in Solid Tumors RECIST criteria
Secondary Objectives
1 This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months stabilization or objective response RECIST criteria and that of response observed after 6 months of treatment
2 The organisational objective is to develop a tumour bank of metastatic colorectal cancer
Population The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab with no heart disease
Techniques Computed tomography CT scan functional imaging ultrasound with SonoVue molecular imaging positron emission tomography PET with fluorodeoxyglucose F18 18-FDG and biology and pathology on microbiopsy of liver metastasis are used
Outcome Criteria The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months
Studied Factors
Radiology
1 CT scan RECIST criteria gold standard
2 Ultrasound with SonoVue injection 1 representative target delay of contrast appearance peak of rising curve of increase and decrease of the signal area under the curve time of average transit
Nuclear Medicine PET scan and 18-FDG standard uptake values SUV
Molecular Characterization of Tumors p53 status microsatellite instability MSI status expression of oncogenes EGFR status VEGF status determination of FcgammaRIIIA polymorphisms
Statistics
1 Descriptive analyses
2 Analysis of the appropriate threshold to measure response to treatment by an ultrasound with SonoVue and by PET scan correlation between response predicted by the ultrasound with SonoVue and the PET conventional morphological CT at 2 months
3 Analysis of prognostic factors
1 Evaluation of the role of each prognostic factor pathology and imaging on response to treatment
2 Multivariate analysis of prognostic factors
3 Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment
Secondary Objectives
1 This trial is also analyzing the correlation between the magnitude of response to treatment at 2 months stabilization or objective response RECIST criteria and that of response observed after 6 months of treatment
2 The organisational objective is to develop a tumour bank of metastatic colorectal cancer
Population The population includes 252 male and female patients with metastatic colorectal cancer justifying the use of cetuximab or bevacizumab with no heart disease
Techniques Computed tomography CT scan functional imaging ultrasound with SonoVue molecular imaging positron emission tomography PET with fluorodeoxyglucose F18 18-FDG and biology and pathology on microbiopsy of liver metastasis are used
Outcome Criteria The primary outcome is response to treatment with monoclonal antibodies according to RECIST criteria at two months
Studied Factors
Radiology
1 CT scan RECIST criteria gold standard
2 Ultrasound with SonoVue injection 1 representative target delay of contrast appearance peak of rising curve of increase and decrease of the signal area under the curve time of average transit
Nuclear Medicine PET scan and 18-FDG standard uptake values SUV
Molecular Characterization of Tumors p53 status microsatellite instability MSI status expression of oncogenes EGFR status VEGF status determination of FcgammaRIIIA polymorphisms
Statistics
1 Descriptive analyses
2 Analysis of the appropriate threshold to measure response to treatment by an ultrasound with SonoVue and by PET scan correlation between response predicted by the ultrasound with SonoVue and the PET conventional morphological CT at 2 months
3 Analysis of prognostic factors
1 Evaluation of the role of each prognostic factor pathology and imaging on response to treatment
2 Multivariate analysis of prognostic factors
3 Analysis of the prognostic power of early response at 2 months on the response observed after 6 months of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None