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

Liver Cancer Clinical Trial

Official title:

Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00152087
• Other study ID #: SJCI015
• Secondary ID: Alison Calkins,
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: September 7, 2005
• Start date: October 2002
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: St. Joseph's Hospital, Florida
• Contact: Mary Pritchard, RN, OCN
• Phone: 813-870-4257
• Email: Mary.Pritchard[@]baycare.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Device:
• Brachytherapy

Locations

Country	Name	City	State
United States	St. Joseph's Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital, Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Primary	- Response to treatment
Primary	- Survival time from treatment
Primary	Safety:
Primary	- Adverse experience

External Links

•   St Joseph's Hospital web site