An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
- Compare and contrast TACE and Y90 in order to determine either equivalence or
superiority as measured by time-to-progression.
- Characterize the safety and toxicity profile of these regimens.
- Determine the need for subsequent treatment in these patients.
- Determine tumor response in these patients
- Characterize change in quality of life and functional status in these patients.
- Determine time to progression in these patients.
OUTLINE: Patients are randomized to receive either TACE or Y90
- Arm I (radioembolization): Patients undergo radioembolization with yttrium Y 90 glass
microspheres by hepatic artery infusion for approximately 1-3 courses.
- Arm II (transarterial chemoembolization [TACE]): Patients undergo TACE with mitomycin
C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for
approximately 1-3 courses.
- In both arms, treatment modifications may apply according to response.
After completion of study treatment, patients are followed every 3 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to progression in patients treated with TACE and Y90
Compare and contrast TACE and Y90 in order to determine either equivalence or superiority as measured by time-to-progression. They have repeat imaging done (MRI or CT) 1 month post procedure and then every 3 months after that.
up to 6 yrs
Riad Salem, MD
United States: Food and Drug Administration
|Northwestern University, Northwestern Memorial Hospital||Chicago, Illinois 60611-3013|