The goal of this phase II clinical trial is to evaluate the efficacy of the completely non-invasive treatment option of stereotactic radiation therapy for the treatment of biopsy proven and growing small renal tumors.
Current treatment options for primary renal cancer include surgery or ablative techniques-all are invasive or minimally invasive options. The completely noninvasive treatment option of stereotactic radiation therapy (SABR), which has become standard of care in many cancer sites, has not been explored for primary renal cancer. With multiple technological advances, it is now feasible to safely treat a moving intra-abdominal tumor such as that in a kidney. This proposed clinical trial evaluates the efficacy of SABR in treating patients with early renal cancers. Growing renal masses will first be biopsied to confirm the diagnosis of renal cancer. Patients will then undergo treatment with SABR of 3-5 fractions completing within three weeks. Treatment response will be evaluated using sequential MRI scans and a second tumor biopsy one year after treatment. Monitoring of treatment toxicity and kidney function will also be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Stereotactic Ablative Body Radiation Therapy (SABR): 3 fractions of 12Gy, or 4 fractions of 10Gy or 5 fractions of 8 Gy
University of Texas Southwestern
Dallas, Texas, United States
Eliminate its growth and tumor viability.
To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
Time frame: 2 years
Adverse events
To describe the adverse events associated with the administration of SABR to renal tumors.
Time frame: 2 years
growth rate of renal tumors
To measure the growth rate of renal tumors after SABR treatment.
Time frame: 2 years
Renal function
To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
Time frame: 2 years
Tumor Viability
To measure tumor viability pathologically one year after SABR treatment with biopsy.
Time frame: one year
progression of disease
To assess radiographic changes to the renal tumor after SABR treatment including tumor viability, enhancement necrosis,T2 tumor cellularity with diffusion-weighted imaging. To assess local, regional and systemic progression of disease after SABR to SRM .To assess time to progression (TTP) of disease from the first SABR treatment. To assess progression free survival (PFS). PFS is defined as the length of time from start of treatment to the time of loco-regional disease progression or death from any cause. To assess overall survival (OS). OS is defined as the duration of time from start of treatment to the time of death from any cause. To assess tumor growth, local failure and indeterminate disease response (IDR).
Time frame: 2 years
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