Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates
- To evaluate and compare the clinical safety of utilizing four different schemes of
radiosurgical ablative techniques for treating poor surgical candidates with renal
- To evaluate and compare the clinical and radiographic efficacy of four different
schemes of radiosurgical ablation of renal tumors in poor surgical candidates.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then
undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or
unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.
After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months
post radiosurgery for a total of 36 months.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of radiosurgery (Phase I)
Acute Radiation Toxicity ≥ grade 3 in the Gastrointestinal and renal/genitourinary categories of the common terminology criteria for adverse events 4.0 (CTCAE) will be considered dose limiting. The maximum tolerated dose will be one dose level below which the adverse event, as described above, occurred.
once every 4 weeks
Rodney Ellis, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|UH-Chagrin Highlands||Orange Village, Ohio 44122|
|UH-Westlake||Westlake, Ohio 44145|