Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039078
Status:
WITHDRAWN
Last Update Posted:
2017-06-26
First Post:
2002-06-06
Brief Title:
Radiolabeled Glass Beads TheraSphere in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Allan Tsung
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Use of TheraSphere for the Treatment of Unresectable Hepatocellular Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Record created in error - not a research study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069336 | REGISTRY | None | None |
| PCI-IRB-000656 | None | None | None |
| PCI-IRB-000871 | None | None | None |
| NCI-V02-1701 | Registry Identifier | PDQ Physician Data Query | None |