Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT02141919
This phase II trial assesses the efficacy of stereotactic ablative body radiation therapy (SABR) for early renal cancer. Patients with biopsy-confirmed tumors receive SABR in 3-5 fractions over three weeks. Efficacy is evaluated via MRI and biopsy one year post-treatment, with monitoring of toxicity and kidney function.
Patient Parameters
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Program Overview
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.
Description
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.
Eligibility Criteria
Exclusion Criteria
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Subject has received any treatment for the treating renal mass; such as RFA or cyroablation.
- If other renal masses received RFA or cryoablation or surgery, then these patients are eligible.
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Subjects received previous abdominal radiation
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Evidence of Metastatic Disease, unless disease-free for ≥ 3 years prior to registration, (non-melanomatous skin cancer and in-situ cancers are okay).
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Female subjects who are pregnant or planning to become pregnant during the course of SABR.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas Southwestern | 75239 | Dallas | Texas |
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