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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. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by St. Joseph's Hospital, Florida.
Recruitment status was:  Recruiting
Information provided by:
St. Joseph's Hospital, Florida Identifier:
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00152087

Contact: Mary Pritchard, RN, OCN 813-870-4257
Contact: Ronda Buffington, RN, OCN 813-870-4123

United States, Florida
St. Joseph's Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Ronda Buffington, RN,OCN    813-870-4123   
Contact: Mary Pritchard, RN, OCN    813-870-4257   
Sponsors and Collaborators
St. Joseph's Hospital, Florida
Principal Investigator: Alison R. Calkins, MD St. Joseph's Hospital, Tampa, FL
  More Information

Additional Information: 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

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

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on August 23, 2017