A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
Conditions
Liver Cancer
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver cancer, Brachytherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Brachytherapy
Type: Device
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: 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
Location
St. Joseph's Hospital
Tampa, Florida, United States
Status: Recruiting
Contact: Ronda Buffington, RN,OCN - 813-870-4123 - Ronda.Buffington@baycare.org
Start Date
October 2002
Completion Date
June 2005
Sponsors
St. Joseph's Hospital, Florida
Source
St. Joseph's Hospital, Florida
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page