Expired Study
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Tampa, Florida 33607


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


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 is Available At:

Original ID:




Secondary ID:

Alison Calkins, MD

Study Acronym:

Brief Title:

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

Official Title:

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

Overall Status:


Study Phase:

Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

St. Joseph's Hospital, Florida

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Alison R. Calkins, MD
Principal Investigator
St. Joseph's Hospital, Tampa, FL
Primary Contact:Mary Pritchard, RN, OCN
Backup Contact:Ronda Buffington, RN, OCN

Study Dates

Start Date:October 2002
Completion Date:June 2005
Verification Date:September 2005
Last Changed Date:September 7, 2005
First Received Date:September 7, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:- Adverse experience
Safety Issues:False
Outcome Type:Primary Outcome
Safety Issues:False
Outcome Type:Primary Outcome
Measure:- Survival time from treatment
Safety Issues:False
Outcome Type:Primary Outcome
Measure:- Response to treatment
Safety Issues:False
Outcome Type:Primary Outcome
Safety Issues:False

Study Interventions

Intervention Type:Device

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:St. Joseph's Hospital, Florida

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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