Expired Study
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Tampa, Florida 33607


Purpose:

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.


Study summary:

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


Criteria:

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


NCT ID:

NCT00152087


Primary Contact:

Principal Investigator
Alison R. Calkins, MD
St. Joseph's Hospital, Tampa, FL

Mary Pritchard, RN, OCN
Phone: 813-870-4257
Email: Mary.Pritchard@baycare.org


Backup Contact:

Email: Ronda.buffington@baycare.org
Ronda Buffington, RN, OCN
Phone: 813-870-4123


Location Contact:

Tampa, Florida 33607
United States

Ronda Buffington, RN,OCN
Phone: 813-870-4123
Email: Ronda.Buffington@baycare.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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