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
Sponsor:
Information provided by:
St. Joseph's Hospital, Florida
ClinicalTrials.gov Identifier:
NCT00152087
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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 2

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:


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
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 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:
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 July 29, 2014