Stereotactic Body Radiation Therapy Versus Radiofrequency Ablation for Small Renal Masses

Study Overview
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Brief Summary
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The execution of this study is pertinent to evaluating SBRT's short- and long-term efficacy and safety in the treatment of SRMs. This study will be the first to compare RFA and SBRT in the treatment of SRMs.

Official Title
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A Prospective Randomized Pilot Trial of Stereotactive Body Radiation Therapy Versus Radiofrequency Ablation for the Management of Small Renal Masses.

Conditions
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Small Renal Masses (SRM)

Intervention / Treatment
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* Procedure: Radiofrequency Ablation
* Radiation: Stereotactive body radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age and capable of providing informed consent Patients scheduled for treatment of their SRM using SBRT or RFA Patients who received a biopsy of their SRM prior to their scheduled SBRT or RFA treatment Patients who are willing to have a biopsy 12 months post-procedure Patients with renal tumor(s) ≤ 4.0 cm Exclusion Criteria: Patients with large renal tumor(s)>4.0 cm Patients who are unable to have a general anesthetic Patients who did not receive a biopsy of their SRM prior to their scheduled SBRT or RFA treatment Patients who are unable to comply with post-operative and/or follow-up protocol/phase of study Evidence of metastatic disease Uncorrectable bleeding diathesis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic body radiation therapy (SBRT)<br> | Radiation: Stereotactive body radiation therapy<br>* The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV.<br>* Other names: SBRT;|
| Active Comparator: Radiofrequency Ablation (RFA)<br> | Procedure: Radiofrequency Ablation<br>* RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures.<br>* Other names: RFA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | Failure will be defined as enhancement of ablated tissue greater than 10 Hounsfield units by CT contrast. | 12 Months | 
| Overall Survival | Defined as post-procedural survival. | 12 Months | 
| Disease free survival | Defined as disease-free survival rate after a single procedure | 12 Months | 
| Disease recurrence | Defined as disease recurrence rate after a single procedure, including positive biopsy result. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour Size | Average percentage decrease in tumor size. | 12 Months | 
| Renal Function -eGFR | Change in eGRF measured by mL/min/1.73m2. | 12 Months | 
| Renal Function - Serum Creatinine | Change in serum creatinine level measured by umol/L. | 12 Months | 
| Renal Function - Creatinine Clearance | Change in creatinine clearance measured by ml/minute. | 12 Months | 
| Complication Rate | Intra and post intervention complication rates will be documented in terms of nausea, vomiting, diarrhea, hematuria, hemorrhage (requiring or not requiring transfusion), perinephric hematoma, ureteral strictures, loss of a renal unit, urinary leak, bleeding, fever and flulike symptoms, stomach/bowel ulceration, ureteropelvic junction obstruction, and upper pole hydrocalycosis. | 12 Months | 
| Number of patients that experienced an adverse event. | Defined by any adverse event listed in the CTCAE. | 12 Months | 
| Change in score for quality of life | Defined by the generic EuroQol (EQ-5D) questionnaire that is a standardized measure of health. A scale of 0-100 (0 being the worse health, and 100 being the best health), is used for a patient to define their overall health and wellbeing. | 12 Months | 
| Duration of hospital stay | Duration of length of hospital stay (if applicable) | Days | 
| Cost analysis | Defined by total cost of procedure and any associated related adverse events post procedure. | 12 Months |