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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
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.
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Maximum tolerated dose of radiation
Time frame: DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity
Time frame: DLT is assessed at 4 and 8 weeks after radiotherapy
Disease-free survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to local progression
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to distant failure
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Disease-specific survival
Time frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
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