Liver Cancer
Conditions
Keywords
Liver cancer, Brachytherapy
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
Interventions
DEVICEBrachytherapy
Sponsors
St. Joseph's Hospital, Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * Pregnant * Fail preliminary MAA testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
| - Response to treatment | — |
| - Survival time from treatment | — |
| Safety: | — |
| - Adverse experience | — |
Countries
United States
Contacts
Primary ContactMary Pritchard, RN, OCN
Backup ContactRonda Buffington, RN, OCN
Outcome results
None listed