An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
18 Years
N/A
Both
Liver Cancer
Trial Information
An Investigator Initiated Multicenter Prospective Randomized Study of Chemoembolization Versus Radioembolization for the Treatment of Hepatocellular Carcinoma (PREMIERE Trial)
OBJECTIVES:
Primary
- Compare and contrast TACE and Y90 in order to determine either equivalence or
superiority as measured by time-to-progression.
Secondary
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Hepatocellular Carcinoma confined to the liver that is unresectable with surgery or
unable to be treated with radiofrequency ablation diagnosed by biopsy or imaging
criteria (CT/MRI)
- No segmental, lobar, or main portal vein thrombosis as evidenced by CT or MRI imaging
PATIENT CHARACTERISTICS:
- Able to carry out activities of daily living, awake > 50% or waking hours
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe cardiac disease
- No active clinically serious infection
- No psychological or physical condition or substance use/abuse that, in the opinion of
the principal investigator or a sub-investigator, would possibly endanger the patient
during study participation or allow for non-compliance with study treatment
PRIOR CONCURRENT THERAPY:
- Prior liver resection allowed
- No prior systemic, ablative, or infusion therapy
- More than 4 weeks since prior major surgery
- Concurrent anticoagulation allowed provided there is documentation that no
coagulation abnormality existed prior to use of anticoagulants
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression in patients treated with TACE and Y90
Outcome Description:
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.
Outcome Time Frame:
up to 6 yrs
Safety Issue:
No
Principal Investigator
Riad Salem, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northwestern University
Authority:
United States: Food and Drug Administration
Study ID:
STU 12339
NCT ID:
NCT00956930
Start Date:
August 2009
Completion Date:
August 2018
Related Keywords:
- Liver Cancer
- advanced adult primary liver cancer
- localized unresectable adult primary liver cancer
- recurrent adult primary liver cancer
- adult primary hepatocellular carcinoma
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| Northwestern University, Northwestern Memorial Hospital | Chicago, Illinois 60611-3013 |
