NCT00152087
Unknown
Phase 2
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
St. Joseph's Hospital, Florida1 site in 1 country25 target enrollmentStarted: October 2002Last updated:
ConditionsLiver Cancer
Overview
- Phase
- Phase 2
- Sponsor
- St. Joseph's Hospital, Florida
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Efficacy
Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Fail preliminary MAA testing
Outcomes
Primary Outcomes
Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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