This is a multicentre, open labeled, controlled phase study designed to assess effectiveness of chemoembolization with LC Beads, both with and without systemic chemotherapy, in the treatment of unresectable liver metastases in patients with colorectal cancer.
This is a multicentre, open labeled, prospective, randomized, controlled phase I/II study designed to assess the clinical performance of chemoembolization with Low Compression Bead (LC Bead), loaded with irinotecan in combination with intravenous chemotherapy and bevacizumab versus intravenous chemotherapy in combination with bevacizumab in the treatment of unresectable liver metastases in patients with colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Chemoembolization using LC beads loaded with 100mg Irinotecan
Oxaliplatin 85 mg/sqm, IV infusion every two weeks
Leucovorin 200 mg/sqm, IV infusion every two weeks
Clearview Cancer Center
Huntsville, Alabama, United States
Radiology Associates of Sacramento/Sutter Cancer Center
Sacramento, California, United States
Emory University
Atlanta, Georgia, United States
Tumor Response
Tumor response will be determined using Modified Response Evaluation Criteria in Solid Tumors (mRECIST). Response will classified as: Complete response - disappearance of all lesions; Partial response - at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter or 30% reduction of arterial enhancement; Progressive disease - at least 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest longest diameter recorded since start of treatment or appearance of one or more new lesions greater than 1cm in size; Stable disease - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since start of treatment.
Time frame: Months 2, 4 and 6
Number of Serious Adverse Events
Total number of serious adverse events that occurred in both Arms of the study.
Time frame: First treatment through one year post treatment completion
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5-Fluorouracil 2400 mg/sqm, IV infusion every 2 week
Bevacizumab 5 mg/kg given at the discretion of the treating physician
Northside Hospital/GA Cancer Specialists
Atlanta, Georgia, United States
University of Louisville
Louisville, Kentucky, United States
Hematology and Oncology Assoc. at Bridgeport
Tupelo, Mississippi, United States
Washington University/Alvin J. Siteman Cancer Center
St Louis, Missouri, United States
Providence Portland Medical Center/Providence Cancer Center
Portland, Oregon, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina