A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

Status unconfirmed · Phase 2

Conditions studied: Liver Cancer

In brief

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.

Key facts

Study ID

NCT00152087

Run by

St. Joseph's Hospital, Florida

People needed

25

Starts

2002-10-01

Expected to finish

2005-06-01

Last updated by the study team

2005-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Co-morbid disease that would place patient at undue risk.
• Pre-existing diarrhea/illness
• Pregnant
• Fail preliminary MAA testing

Where it is running

• St. Joseph's Hospital — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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