Colo-Rectal Cancer MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Sponsors
CHRU TOURS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - patient with non resectable liver metastases from colorectal cancer; patient with minimum two liver metastases which satisfy all the following criteria: diameter between 10 and 35 mm; arterially enhancing liver metastases detected with contrast enhanced ultrasound (CEUS); measurable liver metastases with CT-scan - age = 18 years; - ECOG/OMS 0-1; - life expectancy of at least 12 weeks; - adequate bone marrow, liver and kidney function; - written informed consent obtained from subject; - subjects covered by or having the rights to social security. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Previous systemic or local treatment of liver metastases; - neo-adjuvant or adjuvant chemotherapy/radiotherapy in the 6 months prior to entering the study; - patient with resectable liver metastasis and no contraindication to hepatic resection; - indication for local ablative therapy (radiofrequency ablation or other validated hepatic-directed modality of treatment); - known contraindication to the injection of Sonovue®, of Gadolinium, of iodated contrast agent; - contraindication to MRI or perfusion CT scan; - Patient under legal protection; - Pregnant or lactating woman, or woman with ability to procreate and without contraception; - Inclusion in another therapeutic assay
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the rate of objective response at two months for colorectal liver metastases receiving optimized and targeted delivery of systemic chemotherapy combining bevacizumab and FOLFIRI based on US waves and gaseous microbubbles in colorectal liver metastases compared with those treated with only systemic chemotherapy regimen.;Secondary Objective: - Safety and tolerability based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (semi quantitative score) until D60 - Percent reduction in tumor density on CT scan and MRI from baseline - Assessment of tumor vascularity on CT scan and MRI from baseline - Assessment of tumor vascularity with Dynamic Contrast-Enhanced US (DCE-US) - Biological parameters: dosages and kinetic of bevacizumab and cytokines;Primary end point(s): The objective response will be determined for each selected liver metastasis with spiral CT scan and defined as a decrease of at least 30% in the longest diameter of each selected liver metastases.;Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Safety and tolerability based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (semi quantitative score) until D60 - Percent reduction in tumor density on CT scan and MRI from baseline - Assessment of tumor vascularity on CT scan and MRI from baseline - Assessment of tumor vascularity with Dynamic Contrast-Enhanced US (DCE-US) - Biological parameters: dosages and kinetic of bevacizumab and cytokines;Timepoint(s) of evaluation of this end point: - 2 months - 2 months - 2 months - 2 months - end of the follow-up | — |
Countries
France
Contacts
Public ContactCatherine ROUSSEL
CHRU TOURS
Outcome results
None listed