Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469963
Status:
TERMINATED
Last Update Posted:
2012-09-03
First Post:
2007-05-03
Brief Title:
Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Clinical Trial of Sir Spheres in Patients With Primary Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue
PURPOSE This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery
PURPOSE This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres Sir-Spheres in patients with unresectable primary hepatocellular carcinoma
Secondary
Determine the toxicity of this regimen in these patients
Determine the health-related quality of life of patients receiving this regimen
Determine the survival of patients receiving this regimen
OUTLINE Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin microspheres Sir-Spheres via catheter directly into the hepatic artery on day 1
Health-related quality of life is assessed prior to initial treatment and then periodically thereafter
After completion of study treatment patients are followed periodically for 12-24 months
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Primary
Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres Sir-Spheres in patients with unresectable primary hepatocellular carcinoma
Secondary
Determine the toxicity of this regimen in these patients
Determine the health-related quality of life of patients receiving this regimen
Determine the survival of patients receiving this regimen
OUTLINE Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin microspheres Sir-Spheres via catheter directly into the hepatic artery on day 1
Health-related quality of life is assessed prior to initial treatment and then periodically thereafter
After completion of study treatment patients are followed periodically for 12-24 months
PROJECTED ACCRUAL A total of 35 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VU-VICC-GI-0364 | None | None | None |