Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

Condition	Intervention	Phase
Liver Cancer	Device: Brachytherapy	Phase II

Further Study Details: 

Primary Outcomes: Efficacy; - Response to treatment; - Survival time from treatment; Safety:; - Adverse experience
Expected Total Enrollment:  25

Protocol Objectives include:

• Determine the proportion of patients with HCC in whom the treatment plan can be completed
• Evaluate the response to therapy
• Evaluate toxicities and adverse experiences associated with TheraSphere treatment
• Evaluate survival time

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Over 18 years of age of any sex, race
• Histological proof of HCC
• Able to give Informed Consent
• ECOG performance equal or less than 2
• Life expectancy equal to or greater than 3 months
• Non- pregnant with acceptable contraception in premenopausal women
• Greater than 4 weeks since prior radiation therapy or surgery
• 1 month post chemotherapy
• Serum Bilirubin < 2.0
• Acceptable white blood count

Exclusion Criteria:

• Co-morbid disease that would place patient at undue risk.
• Pre-existing diarrhea/illness
• Pregnant
• Fail preliminary MAA testing

Please refer to this study by ClinicalTrials.gov identifier  NCT00152087

Mary Pritchard, RN, OCN      813-870-4257    Mary.Pritchard@baycare.org
Ronda Buffington, RN, OCN      813-870-4123    Ronda.buffington@baycare.org

Florida
      St. Joseph''''s Hospital, Tampa,  Florida,  33607,  United States; Recruiting

Study chairs or principal investigators

Alison R. Calkins, MD,  Principal Investigator,  St. Joseph''''s Hospital, Tampa, FL   

Study ID Numbers:  SJCI015; Alison Calkins, MD; Matthew Berlet, MD
Last Updated:  September 8, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00152087
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13