The primary aim of this trial is to estimate the duration of hepatic progression-free survival (HPFS) in participants treated with bland embolization (BE), transcatheter arterial Lipiodol chemoembolization (TACE), and embolization by drug-eluting beads (DEB). The primary hypothesis is that chemoembolization will be nearly twice as durable as bland embolization; thatis, the hazard ratio for HPFS will be 1.76 or better.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.
CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.
University of California San Francisco
San Francisco, California, United States
Stanford University
Standford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Abdominal MRI/Triple Phase CT
Hepatic progression-free interval (H-PFS)
Time frame: 2 years
Number of Adverse Events
Symptom-relief interval and toxicity
Time frame: 2 years
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Mount Sinai School of Medicine
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
...and 3 more locations