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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by St. Joseph's Hospital, Florida. Recruitment status was Recruiting

First Received on September 7, 2005. No Changes Posted

Sponsor:	St. Joseph's Hospital, Florida
Information provided by:	St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:	NCT00152087

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.

Condition	Intervention	Phase
Liver Cancer	Device: Brachytherapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital, Florida:

Primary Outcome Measures:

Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience

Estimated Enrollment:	25
Study Start Date:	October 2002
Estimated Study Completion Date:	June 2005

Detailed 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152087

Contacts

Contact: Mary Pritchard, RN, OCN	813-870-4257	Mary.Pritchard@baycare.org
Contact: Ronda Buffington, RN, OCN	813-870-4123	Ronda.buffington@baycare.org

Locations

United States, Florida
St. Joseph's Hospital	Recruiting
Tampa, Florida, United States, 33607
Contact: Ronda Buffington, RN,OCN 813-870-4123 Ronda.Buffington@baycare.org
Contact: Mary Pritchard, RN, OCN 813-870-4257 Mary.Pritchard@baycare.org

Sponsors and Collaborators

St. Joseph's Hospital, Florida

Investigators

Principal Investigator:

Alison R. Calkins, MD

St. Joseph's Hospital, Tampa, FL

More Information

Additional Information:

St Joseph's Hospital web site This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00152087 History of Changes
Other Study ID Numbers:	SJCI015, Alison Calkins, MD, Matthew Berlet, MD
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Joseph's Hospital, Florida:

Liver cancer
Brachytherapy

Additional relevant MeSH terms:

Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases

Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on February 09, 2012