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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA060553 | U.S. NIH Grant/Contract | View source | |
| NU-1365-001 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yttrium Y 90 glass microspheres | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Completion | Proportion of patients completing scheduled treatment plan | Through study completion, up to 24 months or when patient discontinues treatment for whatever reason. |
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DISEASE CHARACTERISTICS:
Confirmed diagnosis of intrahepatic carcinoma
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:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Any of the following contraindications to angiography and selective visceral 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:
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Patients with unresectable cancer primarily in the liver with the liver being the only site of disease or the dominant site of disease
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| Name | Affiliation | Role |
|---|---|---|
| Riad Salem, MD | Robert H. Lurie Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19766639 | Result | Salem R, Lewandowski RJ, Mulcahy MF, Riaz A, Ryu RK, Ibrahim S, Atassi B, Baker T, Gates V, Miller FH, Sato KT, Wang E, Gupta R, Benson AB, Newman SB, Omary RA, Abecassis M, Kulik L. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010 Jan;138(1):52-64. doi: 10.1053/j.gastro.2009.09.006. Epub 2009 Sep 18. |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |