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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.

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

Study Description
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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

Study Design
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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
U.S. FDA Resources

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
St Joseph's Hospital web site  This link exits the ClinicalTrials.gov site
web site for Dr. Alison Calkins, Investigator  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00152087     History of Changes
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
Brachytherapy

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Liver Diseases