Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466856
Status:
TERMINATED
Last Update Posted:
2012-05-18
First Post:
2007-04-25
Brief Title:
Internal Radiation Therapy in Treating Patients With Liver Metastases From Neuroendocrine Tumors
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Clinical Trial of Sir-Spheres in Patients With Symptomatic or Progressive Hepatic Metastases From Neuroendocrine Tumors
Status:
TERMINATED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to 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 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 phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors
PURPOSE This phase II trial is studying how well internal radiation therapy works in treating patients with liver metastases from neuroendocrine tumors
Detailed Description:
OBJECTIVES
Primary
Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres Sir-Spheres in patients with progressive liver metastases from neuroendocrine tumors
Secondary
Determine the toxicity of this treatment in these patients
Determine the symptomatic relief of patients treated with this regimen
Determine the health-related quality of life of patients receiving this treatment
OUTLINE Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres Sir-Spheres via the catheter on day 1 Patients also receive octreotide acetate IV 1 hour prior to during and 2 hours after Sir-Spheres injection Patients may undergo above treatment in another lobe of the liver if each lobe is treated separately 4 weeks later
Patients undergo functional performance health-related quality of life and symptom severity assessment prior to initial treatment and after completion of study treatment
After completion of study treatment patients are followed periodically for at least 1 year
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Primary
Determine tumor response to selective internal radiation therapy with yttrium Y 90 resin microspheres Sir-Spheres in patients with progressive liver metastases from neuroendocrine tumors
Secondary
Determine the toxicity of this treatment in these patients
Determine the symptomatic relief of patients treated with this regimen
Determine the health-related quality of life of patients receiving this treatment
OUTLINE Patients have an catheter placed into the hepatic artery percutaneously through the groin and then undergo selective internal radiation therapy with yttrium Y 90 resin microspheres Sir-Spheres via the catheter on day 1 Patients also receive octreotide acetate IV 1 hour prior to during and 2 hours after Sir-Spheres injection Patients may undergo above treatment in another lobe of the liver if each lobe is treated separately 4 weeks later
Patients undergo functional performance health-related quality of life and symptom severity assessment prior to initial treatment and after completion of study treatment
After completion of study treatment patients are followed periodically for at least 1 year
PROJECTED ACCRUAL A total of 25 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-0365 | None | None | None |