Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445757
Status:
WITHDRAWN
Last Update Posted:
2012-03-20
First Post:
2007-03-07
Brief Title:
Stereotactic Radiation Therapy 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
Status:
WITHDRAWN
Status Verified Date:
2012-03
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 Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors
PURPOSE This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors
Determine radiotherapy-associated toxicity in these patients
Secondary
Determine preoperative pathologic response to this regimen in these patients
OUTLINE This is a dose-escalation study of radiotherapy
Radiotherapy Patients undergo stereotactic radiotherapy to 1 tumor Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose MTD or upper limit is reached The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity DLT DLT is assessed at 4 and 8 weeks after radiotherapy
Surgery Two months after completion of radiotherapy patients undergo preoperative assessment of tumor response followed by partial nephrectomy
After completion of study therapy patients are followed periodically for at least 2 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors
Determine radiotherapy-associated toxicity in these patients
Secondary
Determine preoperative pathologic response to this regimen in these patients
OUTLINE This is a dose-escalation study of radiotherapy
Radiotherapy Patients undergo stereotactic radiotherapy to 1 tumor Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose MTD or upper limit is reached The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity DLT DLT is assessed at 4 and 8 weeks after radiotherapy
Surgery Two months after completion of radiotherapy patients undergo preoperative assessment of tumor response followed by partial nephrectomy
After completion of study therapy patients are followed periodically for at least 2 years
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| CASE5806 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |