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The purpose of this study is to provide supervised access to treatment with TheraSphere® to eligible patients with primary and metastatic cancer and evaluate response to treatment, survival and toxicity.
The study has the following objectives:
This study will use angiographic administration of radioactive TheraSphere® Yttirum-90 microspheres into the hepatic artery, to treat 50 patients with primary or secondary cancer involving the liver. The study population are those who have failed standard therapies, have a majority of their cancer in the liver, have a good performance status and reasonable hepatic function. Outcomes being studied are response to treatment, survival and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraSphere | Other | Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver -------------------------------------------------------------------------------- |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yttrium Y 90 microspheres (TheraSphere®) | Device | Y-90 is incorporated into very tiny glass beads, it can be injected into the liver through the blood vessels supplying the liver |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rates, in terms of size, volume, contrast enhancement and PET avidity | 2 to 3 months after treatment(s) up to 2 years | |
| Toxicity, which may include radiation induced liver damage, pain, consequences of shunting, toxic deaths. | 2 years | |
| Survival time | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P Flynn, MD | Southwestern Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Treatment Centers of America at Southwestern Regional Medical Center | Tulsa | Oklahoma | 74133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11229728 | Background | Campbell AM, Bailey IH, Burton MA. Tumour dosimetry in human liver following hepatic yttrium-90 microsphere therapy. Phys Med Biol. 2001 Feb;46(2):487-98. doi: 10.1088/0031-9155/46/2/315. | |
| 11951213 | Background | Herba MJ, Thirlwell MP. Radioembolization for hepatic metastases. Semin Oncol. 2002 Apr;29(2):152-9. doi: 10.1053/sonc.2002.31672. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 12029557 | Background | Wong CY, Salem R, Raman S, Gates VL, Dworkin HJ. Evaluating 90Y-glass microsphere treatment response of unresectable colorectal liver metastases by [18F]FDG PET: a comparison with CT or MRI. Eur J Nucl Med Mol Imaging. 2002 Jun;29(6):815-20. doi: 10.1007/s00259-002-0787-4. Epub 2002 Mar 29. |
| 15713920 | Background | Goin JE, Salem R, Carr BI, Dancey JE, Soulen MC, Geschwind JF, Goin K, Van Buskirk M, Thurston K. Treatment of unresectable hepatocellular carcinoma with intrahepatic yttrium 90 microspheres: a risk-stratification analysis. J Vasc Interv Radiol. 2005 Feb;16(2 Pt 1):195-203. doi: 10.1097/01.RVI.0000142602.79459.90. |
| 16002501 | Background | Murthy R, Xiong H, Nunez R, Cohen AC, Barron B, Szklaruk J, Madoff DC, Gupta S, Wallace MJ, Ahrar K, Hicks ME. Yttrium 90 resin microspheres for the treatment of unresectable colorectal hepatic metastases after failure of multiple chemotherapy regimens: preliminary results. J Vasc Interv Radiol. 2005 Jul;16(7):937-45. doi: 10.1097/01.RVI.0000161142.12822.66. |
| 16105922 | Background | Wong CY, Qing F, Savin M, Campbell J, Gates VL, Sherpa KM, Lewandowski RJ, Nagle C, Salem R. Reduction of metastatic load to liver after intraarterial hepatic yttrium-90 radioembolization as evaluated by [18F]fluorodeoxyglucose positron emission tomographic imaging. J Vasc Interv Radiol. 2005 Aug;16(8):1101-6. doi: 10.1097/01.RVI.0000168104.32849.07. |
| 16371529 | Background | Salem R, Lewandowski RJ, Atassi B, Gordon SC, Gates VL, Barakat O, Sergie Z, Wong CY, Thurston KG. Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): safety, tumor response, and survival. J Vasc Interv Radiol. 2005 Dec;16(12):1627-39. doi: 10.1097/01.RVI.0000184594.01661.81. |
| 16371530 | Background | Lewandowski RJ, Thurston KG, Goin JE, Wong CY, Gates VL, Van Buskirk M, Geschwind JF, Salem R. 90Y microsphere (TheraSphere) treatment for unresectable colorectal cancer metastases of the liver: response to treatment at targeted doses of 135-150 Gy as measured by [18F]fluorodeoxyglucose positron emission tomography and computed tomographic imaging. J Vasc Interv Radiol. 2005 Dec;16(12):1641-51. doi: 10.1097/01.RVI.0000179815.44868.66. |
| 16999596 | Background | Wong CY, Savin M, Sherpa KM, Qing F, Campbell J, Gates VL, Lewandowski RJ, Cheng V, Thie J, Fink-Bennett D, Nagle C, Salem R. Regional yttrium-90 microsphere treatment of surgically unresectable and chemotherapy-refractory metastatic liver carcinoma. Cancer Biother Radiopharm. 2006 Aug;21(4):305-13. doi: 10.1089/cbr.2006.21.305. |
| 17056999 | Background | Salem R, Thurston KG. Radioembolization with yttrium-90 microspheres: a state-of-the-art brachytherapy treatment for primary and secondary liver malignancies: part 3: comprehensive literature review and future direction. J Vasc Interv Radiol. 2006 Oct;17(10):1571-93. doi: 10.1097/01.RVI.0000236744.34720.73. |
| 16729228 | Background | Sato K, Lewandowski RJ, Bui JT, Omary R, Hunter RD, Kulik L, Mulcahy M, Liu D, Chrisman H, Resnick S, Nemcek AA Jr, Vogelzang R, Salem R. Treatment of unresectable primary and metastatic liver cancer with yttrium-90 microspheres (TheraSphere): assessment of hepatic arterial embolization. Cardiovasc Intervent Radiol. 2006 Jul-Aug;29(4):522-9. doi: 10.1007/s00270-005-0171-4. |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |