Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458484
Status:
COMPLETED
Last Update Posted:
2020-07-22
First Post:
2007-04-09
Brief Title:
Radiosurgery in Treating Patients With Kidney Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue
PURPOSE This phase III trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery
PURPOSE This phase III trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery
Detailed Description:
OBJECTIVES
Primary
To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors
Secondary
To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates
Serum Blood Marker Objective
To determine if serum markers collected before and after radiation may give a predictive indication of tumor response
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity Treatment may repeat at 6 months if tumor is still present
After radio-surgery follow-up will be done at 1 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
Primary
To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors
Secondary
To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates
Serum Blood Marker Objective
To determine if serum markers collected before and after radiation may give a predictive indication of tumor response
OUTLINE This is a phase I dose-escalation study followed by a phase II study
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity Treatment may repeat at 6 months if tumor is still present
After radio-surgery follow-up will be done at 1 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-2010-01064 | OTHER | NCICTRP | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CASE12806 | OTHER | None | None |