Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-26 @ 7:22 AM
Study NCT ID:
NCT00445757
Status:
WITHDRAWN
Last Update Posted:
2012-03-20
First Post:
2007-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
Sponsor:
Case Comprehensive Cancer Center
Organization:
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WITHDRAWN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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| CASE5806 | OTHER | Case Comprehensive Cancer Center | View |