Liver Cancer
Conditions
Keywords
localized unresectable adult primary liver cancer, recurrent adult primary liver cancer, adult primary hepatocellular carcinoma
Brief summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying the side effects of hepatic arterial infusion using yttrium-90 microspheres (TheraSphere®) to see how well it works in treating patients with liver cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: * Provide supervised access to yttrium-90 glass microspheres (TheraSphere®) for patients with unresectable hepatocellular carcinoma. * Determine the response in patients with unresectable hepatocellular carcinoma treated with hepatic arterial infusion of yttrium-90 glass microspheres. * Determine the toxic effects and adverse experiences associated with this therapy in these patients. * Determine the survival time of patients treated with this therapy. * Determine the time to progression of disease in the liver, duration of response, and progression-free interval of patients treated with this therapy. * Evaluate the influence of pretreatment characteristics on efficacy parameters in patients treated with this therapy. * Assess the quality of life of patients treated with this therapy. OUTLINE: Radioactive material yttrium-90 glass microspheres (TheraSphere®) is infused directly into a liver tumor in order to kill tumor cells and cause less damage to the normal tissue. Patients receive TheraSphere® via hepatic arterial infusion on day 1. This artery is accessed through the femoral artery in the groin. This procedure is generally completed on an outpatient basis. Patients may receive a single dose to the whole liver, or sequential treatments to each side of the liver approximately 30 to 90 days apart. Patients may be re-treated at a later time. Patients are followed every 2 to 4 months for the rest of their lives to access tumor progression, symptom management and quality of life.
Interventions
RADIATIONyttrium Y 90 glass microspheres
Sponsors
Allan Tsung
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Confirmed diagnosis of hepatocellular carcinoma (HCC) * Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass in addition to known laboratory or clinical risk factors for HCC, and/or an elevated alpha-fetoprotein (AFP) level * No significant extrahepatic disease that may represent an imminent life-threatening outcome * No evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiotherapy to the lungs on either the first yttrium-90 glass microspheres (TheraSphere®) administration or with cumulative delivery of radiation to the lungs over multiple treatments due to any angiographically uncorrectable flow to the gastrointestinal tract PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * No hepatic dysfunction * Bilirubin ≤ 2.0 mg/dL * No vascular abnormalities or severe peripheral vascular disease that would preclude angiography or selective visceral catheterization * No pulmonary insufficiency * No evidence of detectable technetium Tc 99m macroaggregates of albumin flow to the stomach or duodenum after application of established angiographic techniques to stop such flow * No contraindications to angiography * No contraindications to selective visceral catheterization * No other condition or cormorbidity that would preclude study treatment * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 30 days after study PRIOR CONCURRENT THERAPY: * At least 1 month since prior chemotherapy, radiotherapy, or surgery * No other concurrent investigational agents or anticancer therapy for HCC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment | — |
| Survival time from treatment | — |
| Adverse experiences | — |
Countries
United States
Outcome results
None listed