SABR for Renal Tumors

Study Overview
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Brief Summary
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Renal Cell Carcinoma (RCC) is the most common type of kidney cancer. The usual treatment for this type of cancer is surgery. Considering the most common patients are an average age of 65 and some are not suitable candiates for surgery, there is great interest in non-surgical alternatives for kidney cancer treatments. This study will investigate the use of Stereotactic Ablative Radiosurgery (SABR) for renal tumors. SABR is a non-invasive alternative, which involves delivery of high doses of radiation to the target, while minimizing the risk of injury to the surrounding organs. Patients will be seen before and end of treatmetn and will be followed at 4 month intervals for up to 2 years. During the follow ups, patients will be asked to complete a quality of life questionnaire and will have standard of care imaging.

Official Title
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Phase II Study: Stereotactic Ablative Radiotherapy for Renal Tumors

Conditions
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Renal Tumor

Intervention / Treatment
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* Radiation: Stereotactic Ablative Radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid Kidney Mass (primary RCC or metastasis) amenable to SABR ≤6cm Histological or radiological diagnosis of renal tumor Inoperable: High risk for surgery or declined surgery ECOG performance status of 0-3 Exclusion Criteria: ≥5 active metastases Sysstemic therapy (except endocrine therapy) wthin 6 days prior to SABR Prior abdominal radiotherapy with fields overlap resulting in excessive doses to the involved kidney Patients with end stage renal failure > 4(KDOQI guidelines) Familial Syndrome: Von Hippel-Lindau disease, Polycystic Kidney Disease, Hereditary Papillary RCC or Tuber Sclerosis

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Ablative Radiotherapy<br>Adult patients with Kidney mass (either primary or metastasis) amenable to SABR | Radiation: Stereotactic Ablative Radiotherapy<br>* Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the radiation induced renal impairments in patients receiving SABR. | The prevalence of nephron toxicity in patients treated with SABR, measured by the change in Glomerular Filtration Rate (GFR) every 4 months over 2 years. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Kidney Disease Stage Progression | Chronic kidney disease stage progression after SABR, assessed by the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines | 2 years | 
| 2-year Local recurrence rate | 2 year local recurrence rate of kidney tumors treated with SABR, measured by assessing the change of irradiated kidney function on functional imaging. | 2 years | 
| Patient Reported Outcomes | The change in quality of life of patients treated with SABR, assessed through the use of NCCN FKSI-19 questionnaire. | 2 years | 
| Incidence of acute and late toxicities | The incidence of acute (≤3 months) and late complication of interest (GI or GU complications, high blood pressure and adrenal insufficiency) as assessed by CTCAE version 5.0. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stereotactic Body Radiation Therapy, SABR, Radiation Therapy, Renal Cell Carcinoma, RCC