Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
18 Years
N/A
Both
Liver Cancer
Trial Information
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Principal Investigator
Alison R. Calkins, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Joseph's Hospital, Tampa, FL
Authority:
United States: Food and Drug Administration
Study ID:
SJCI015
NCT ID:
NCT00152087
Start Date:
October 2002
Completion Date:
June 2005
Related Keywords:
- Liver Cancer
- Liver cancer
- Brachytherapy
- Liver Neoplasms
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| St. Joseph's Hospital | Tampa, Florida 33607 |
