Status:
TERMINATED
Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Liver Cancer
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical...
Detailed Description
OBJECTIVES: Primary * Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular ...
Eligibility Criteria
Inclusion
- Diagnosis of hepatocellular carcinoma
- Not amenable to surgical resection or immediate liver transplantation
- Destaging of tumor prior to surgical resection or transplantation allowed
- Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan
- No equivocal, nonmeasurable, or nonevaluable liver cancer
- No more than 75% replacement of normal liver by tumor
- Cancer of the Liver Italian Program (CLIP) stage 1-3 disease
- No extra-hepatic metastases as determined by CT scan or MRI
Exclusion
- Life expectancy ≥ 3 months
- Karnofsky performance status 50-100%
- Creatinine ≤ 1.5 mg/dL
- Bilirubin ≤ 2.0 mg/dL
- Albumin ≥ 3 g/dL
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 65,000/mm³
- INR ≤ 1.4
- Hemoglobin \> 9 g/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
- No hepatic arterial anatomy that would prevent the administration of study drug into the liver
- Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
- No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
- More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
- No prior radiotherapy to the upper abdomen that included the liver in the treatment field
- No capecitabine within 8 weeks before or after study treatment
- No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatment
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00469963
Start Date
December 1 2003
End Date
April 1 2007
Last Update
September 3 2012
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838