Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Stopped early · Not applicable

Conditions studied: Liver Cancer

In brief

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 trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.

Key facts

Study ID

NCT00469963

Run by

Vanderbilt-Ingram Cancer Center

People needed

12

Starts

2003-12-01

Expected to finish

2007-04-01

Last updated by the study team

2012-09-03

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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