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Trial Title:
A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.
NCT ID:
NCT00152087
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
Liver cancer
Brachytherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Brachytherapy
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St. Joseph's Hospital
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronda Buffington, RN,OCN
Phone:
813-870-4123
Email:
Ronda.Buffington@baycare.org
Contact backup:
Last name:
Mary Pritchard, RN, OCN
Phone:
813-870-4257
Email:
Mary.Pritchard@baycare.org
Start date:
October 2002
Completion date:
June 2005
Lead sponsor:
Agency:
St. Joseph's Hospital, Florida
Agency class:
Other
Source:
St. Joseph's Hospital, Florida
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00152087
http://www.sjbhealth.org
