Liver Cancer
Conditions
Keywords
adult primary hepatocellular carcinoma, localized unresectable adult primary liver cancer, advanced adult primary liver cancer
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 how well radiolabeled glass beads work in treating patients with liver cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: * Provide supervised access to treatment with yttrium Y 90 glass microspheres (TheraSphere®) to eligible patients with cancer of the liver who are not candidates for surgical resection. * Evaluate patient experience and toxicities associated with yttrium Y 90 glass microspheres (TheraSphere®) treatment. OUTLINE: This is a humanitarian device exemption use study. Patients receive yttrium Y 90 glass microspheres (TheraSphere®) into the liver tumor through a percutaneously placed catheter into the hepatic artery. Patients may receive additional treatment 4-12 weeks after initial treatment at the discretion of the study physician. After completion of study treatment, patients are followed at 2 weeks, 30 days, and then once a year for approximately 2 years.
Interventions
RADIATIONyttrium Y 90 glass microspheres
The target dose of TheraSphere® is 80-150 Gy (8,000-15,000 rad). Patients may receive a single dose to the whole liver, or lobar treatment delivered as a sequence of treatments approximately 30 -90 days apart.
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Confirmed diagnosis of intrahepatic carcinoma * Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP * Unresectable disease * No portal hypertension with portal venous shunt away from the liver * No significant extrahepatic disease representing an imminent life-threatening outcome * No evidence of potential delivery of \> 16.5 mCi (30 Gy absorbed dose) radiation to the lungs on either of the following: * First yttrium Y 90 glass microspheres (TheraSphere®) administration * Cumulative delivery of radiation to the lungs over multiple treatments PATIENT CHARACTERISTICS: Inclusion criteria: * ECOG performance status 0-2 * Absolute granulocyte count ≥ 1,500/μL * Platelet count \> 25,000/μL * Serum creatinine \< 2.0 mg/dL (unless using non-iodinated contrast or on dialysis) * Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin and the tumor may be isolated from a vascular standpoint, treatment may proceed) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception
Exclusion criteria
* Any of the following contraindications to angiography and selective visceral catheterization: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization * Evidence of any detectable Tc-99 macroaggregated albumin flow to the stomach or duodenum, after application of established angiographic techniques to stop such flow * Severe liver dysfunction or pulmonary insufficiency * Active uncontrolled infection * Significant underlying medical or psychiatric illness PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior and no other concurrent anticancer therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Completion | Through study completion, up to 24 months or when patient discontinues treatment for whatever reason. | Proportion of patients completing scheduled treatment plan |
Countries
United States
Outcome results
None listed