Back to resultsA Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
Primary Purpose
Liver Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brachytherapy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring Liver cancer, Brachytherapy
Eligibility 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
Sites / Locations
- St. Joseph's HospitalRecruiting
Outcomes
Primary Outcome Measures
Efficacy
- Response to treatment
- Survival time from treatment
Safety:
- Adverse experience
Secondary Outcome Measures
Full Information
NCT ID
NCT00152087
First Posted
September 7, 2005
Last Updated
September 7, 2005
Sponsor
St. Joseph's Hospital, Florida
1. Study Identification
Unique Protocol Identification Number
NCT00152087
Brief Title
A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
Official Title
Treatment of Unresectable Hepatocellular Carcinoma With Therasphere. A Human Device Evaluation Protocol.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
St. Joseph's Hospital, Florida
4. Oversight
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Liver cancer, Brachytherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Brachytherapy
Primary Outcome Measure Information:
Title
Efficacy
Title
- Response to treatment
Title
- Survival time from treatment
Title
Safety:
Title
- Adverse experience
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Pritchard, RN, OCN
Phone
813-870-4257
Email
Mary.Pritchard@baycare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ronda Buffington, RN, OCN
Phone
813-870-4123
Email
Ronda.buffington@baycare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison R. Calkins, MD
Organizational Affiliation
St. Joseph's Hospital, Tampa, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronda Buffington, RN,OCN
Phone
813-870-4123
Email
Ronda.Buffington@baycare.org
First Name & Middle Initial & Last Name & Degree
Mary Pritchard, RN, OCN
Phone
813-870-4257
Email
Mary.Pritchard@baycare.org
12. IPD Sharing Statement
Links:
URL
http://www.sjbhealth.org
Description
St Joseph's Hospital web site
URL
http://www.tampabaycancer.com
Description
web site for Dr. Alison Calkins, Investigator
Learn more about this trial
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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