This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma. Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
209
Overall Survival (OS)
OS defined as the time interval between the date of randomization and the date of death from any cause.
Time frame: From date of randomization until the date of death from any cause assessed up 3 yrs 8 months
Progression-free Survival
PFS defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as an increase in the sum of the longest diameters of ≥ 20% and an absolute increase in the sum of the longest diameters of ≥ 5 mm, or the appearance of a new lesion.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years 8 months.
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City of Hope
Duarte, California, United States
Orlando Health
Orlando, Florida, United States
Memorial Healthcare
Pembroke Pines, Florida, United States
University of Illinois Chicago
Chicago, Illinois, United States
Adventist Midwest Health
Hinsdale, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Lenox Hill Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
...and 73 more locations