Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT00327093
Status:
TERMINATED
Last Update Posted:
2009-02-09
First Post:
2006-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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 and/or 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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: