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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
- 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
- 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
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