A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
| Status: | Completed |
|---|---|
| Conditions: | Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2002 |
| End Date: | June 2005 |
| Contact: | Mary Pritchard, RN, OCN |
| Email: | Mary.Pritchard@baycare.org |
| Phone: | 813-870-4257 |
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
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.
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.
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
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
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