Carcinoma, Hepatocellular, Liver Neoplasms
Conditions
Keywords
Therasphere, Yttrium, liver, cancer, radiation
Brief summary
The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity. The study has the following objectives: * Provide supervised access to treatment with TheraSphere to eligible patients with primary and metastatic cancer to the liver. * Evaluate patient experience and toxicities associated with TheraSphere treatment * Evaluate predisposing factors that may influence results and toxicity
Detailed description
This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity. 1. Range of patients who can be offered TheraSphere® 2. Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity 3. Survival time 4. Determine response in relation to histology and other parameters 5. Ability to tolerate repeat treatments 6. Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.
Interventions
Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver
Sponsors
Southwestern Regional Medical Center
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
1. Age \>= 18. 2. Cancer visible in liver on CT,MR,US or PET scan. 3. Primary cancer in the liver (hepatocellular carcinoma), or metastatic cancer involving the liver from a primary such as but not limited to lung, breast, colon, upper GI, neuroendocrine, melanoma. 4. Life expectancy greater than 2 months 5. Performance status of ECOG 2 or better (Ambulatory and capable of all selfcare, but unable to carry out any work activities. Up and about more than 50% of waking hours.) 6. Patients have tried and/or are aware of all FDA approved therapies for their condition.
Exclusion criteria
1. Vascular shunt that cannot be corrected. 2. Bulky cancer outside of liver. Active cancer within the liver should be a greater volume than the active cancer outside the liver / in the remainder of body. 3. Pregnancy 4. Hematologic primary such as lymphoma, leukemia, myeloma. 5. Body weight 300 lbs. and above 6. Evidence of portal hypertension, splenomegaly or ascites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity | 2 to 3 months after treatment(s) up to 2 years |
| Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. | 2 years |
| Survival time | 2 years |
Countries
United States
Outcome results
None listed