Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
- Determine the maximum tolerated dose of radiation in patients undergoing stereotactic
radiotherapy for renal tumors.
- Determine radiotherapy-associated toxicity in these patients.
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of radiation
DLT is assessed at 4 and 8 weeks after radiotherapy
Lee E. Ponsky, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|