Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors
- Conditions
- Kidney Cancer
- Registration Number
- NCT00445757
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Maximum tolerated dose of radiation DLT is assessed at 4 and 8 weeks after radiotherapy Radiotherapy-associated toxicity DLT is assessed at 4 and 8 weeks after radiotherapy
- Secondary Outcome Measures
Name Time Method Disease-free survival follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery Time to local progression follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery Time to distant failure follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery Survival follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery Disease-specific survival follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Trial Locations
- Locations (1)
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States