Stereotactic Ablative Body Radiation Therapy for Patients With Primary Renal Cancer
- Conditions
- Renal Cancers
- Interventions
- Radiation: Stereotactic Ablative Radiation Therapy
- Registration Number
- NCT02141919
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
-
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.
-
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).
-
Female subjects who are pregnant or planning to become pregnant during the course of SABR.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stereotactic Ablative Radiation Therapy Stereotactic Ablative Radiation Therapy Stereotactic Ablative Radiation Therapy (SABR)
- Primary Outcome Measures
Name Time Method Eliminate its growth and tumor viability. 2 years To evaluate if SABR to small renal tumors is able to eliminate its growth and viable tumor.
- Secondary Outcome Measures
Name Time Method growth rate of renal tumors 2 years To measure the growth rate of renal tumors after SABR treatment.
progression of disease 2 years 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).Adverse events 2 years To describe the adverse events associated with the administration of SABR to renal tumors.
Tumor Viability one year To measure tumor viability pathologically one year after SABR treatment with biopsy.
Renal function 2 years To measure the changes in kidney function, creatinine levels, renal perfusion and GFR after SABR treatment
Trial Locations
- Locations (1)
University of Texas Southwestern
🇺🇸Dallas, Texas, United States