Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Study Overview
=================
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. Range of patients who can be offered TheraSphere® Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity Survival time Determine response in relation to histology and other parameters Ability to tolerate repeat treatments Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths.

Official Title
-----------------
Use of TheraSphere® Yttrium-90 Glass Microspheres for Primary and Metastatic Liver Tumors

Conditions
-----------------
Carcinoma, Hepatocellular, Liver Neoplasms

Intervention / Treatment
-----------------
* Device: yttrium Y 90 microspheres (TheraSphere®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18. Cancer visible in liver on CT,MR,US or PET scan. 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. Life expectancy greater than 2 months 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.) Patients have tried and/or are aware of all FDA approved therapies for their condition. Exclusion Criteria: Vascular shunt that cannot be corrected. 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. Pregnancy Hematologic primary such as lymphoma, leukemia, myeloma. Body weight 300 lbs. and above Evidence of portal hypertension, splenomegaly or ascites.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TheraSphere<br>Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver -------------------------------------------------------------------------------- | Device: yttrium Y 90 microspheres (TheraSphere®)<br>* Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Therasphere, Yttrium, liver, cancer, radiation