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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152087
Recruitment Status : Unknown
Verified September 2005 by St. Joseph's Hospital, Florida.
Recruitment status was:  Recruiting
First Posted : September 9, 2005
Last Update Posted : September 9, 2005
Information provided by:
St. Joseph's Hospital, Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Device: Brachytherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
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.
Study Start Date : October 2002
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Primary Outcome Measures :
  1. Efficacy
  2. - Response to treatment
  3. - Survival time from treatment
  4. Safety:
  5. - Adverse experience

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152087

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

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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
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Principal Investigator: Alison R. Calkins, MD St. Joseph's Hospital, Tampa, FL
Additional Information:
Layout table for additonal information Identifier: NCT00152087    
Other Study ID Numbers: SJCI015
Alison Calkins, MD
Matthew Berlet, MD
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 9, 2005
Last Verified: September 2005
Keywords provided by St. Joseph's Hospital, Florida:
Liver cancer
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases