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Early ultrasonography role by Contrast enhanced ultrasonography ( CEUS) evaluating therapy effectiveness in patients with hepatic metastasis of colorectal cancer treated with antiangiogenetic drug.

ABSTRACT: Primary objectives: assessment, by CEUS, of early response to antiangiogenic treatment in patients with liver mets from colorectal cancer treated by Bevacizumab plus Folfiri every 14 days (or by other protocols including 5FU and Irinotecan plus bevacizumab). Aim: Early assessment of the antiangiogenetic effectiveness of bevacizumab studied by CEUS vs RECIST criteria. Theﾓtargetﾔ lesions are only the ones measurable and the ones susceptible of reiterable measuring in CEUS. After US identification of a ﾓtargetﾔ lesion the microcirculation of which will be evaluated by CEUS. Primary endpoints: Early assessment of the antiangiogenetic effectivenes of bevacizumab studied by CEUS vs RECIST criteria

DISEASE(S): Methastatic Colorectal Cancer,Colon Neoplasm

PROVIDER: 2522056 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description: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.

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Early ultrasonography role by Contrast enhanced ultrasonography ( CEUS) evaluating therapy effectiveness in patients with hepatic metastasis of colorectal cancer treated with antiangiogenetic drug.

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