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
- Registration Number
- NCT00152087
- Lead Sponsor
- St. Joseph's Hospital, Florida
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- 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
- Co-morbid disease that would place patient at undue risk.
- Pre-existing diarrhea/illness
- Pregnant
- Fail preliminary MAA testing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy - Response to treatment - Survival time from treatment Safety: - Adverse experience
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St. Joseph's Hospital
🇺🇸Tampa, Florida, United States