Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney

Study Overview
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Brief Summary
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This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.

Detailed Description
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Who is it for? Age > 18 years old All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney ECOGperformance of 0-2 inclusive. Life expectancy > 9 months Either medically inoperable, technically high risk for surgery or decline surgery. Multidisciplinary decision for active treatment Study Details: Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered radioresistant to fully fractionated EBRT. In an effort to overcome the perceived radioresistance of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney. Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only). All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR. The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

Official Title
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Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney, a Phase II Clinical Trial (FASTRACK II)

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Radiation: SABR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years old All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive. Life expectancy > 9 months Either medically inoperable, technically high risk for surgery or decline surgery. Multidisciplinary decision for active treatment Exclusion Criteria: Pre-treatment estimated glomerular filtration rate < 30 mls/min Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy. Previous high-dose radiotherapy to an overlapping region Tumours of larger than 8cm is size

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
Interventional Model Description: Radiotherapy; Fraction schedule 1: 26Gy in 1 fraction, for tumours < 4cm in size Fraction schedule 2: 42Gy in 3 fractions, for tumours > 4cm in size
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stereotactic Ablative Body Radiotherapy<br>Stereotactic Ablative Body Radiotherapy (SABR) Treatment schedule 1: 26 Gray (Gy) in 1 fraction, for tumours of less than or equal to 4cm in size. Treatment schedule 2: 42 Gray (Gy) in 3 fractions, for tumours of greater than 4cm in size | Radiation: SABR<br>* Renal cell carcinoma (RCC) is conventionally considered radioresistant to fully fractionated EBRT. In an effort to overcome the perceived radioresistance of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy.<br>* Other names: Stereotactic Ablative Body Radiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria | Responsive Evaluation Criteria in Solid Tumors (RECIST) | 12mths post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4 | Common Terminology Criteria for Adverse Events (CTCAE) | From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment | 
| Estimated Survival after SABR assessed by clinincal assessment | Stereotactic Ablative Radiotherapy (SABR) | assessed up to 60 months | 
| Estimated Distant Failure Rate after SABR assessed by CT scan and clinical assessment |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed from 6 mths, 9 mths, 12 mths, 18mths, 33 mths, 42 mths, 51 mths, and 60 mths post treatment | 
| Renal Function Change after SABR assessed by split renal function and GFR | Calculated Glomular Filtration Rate (GFR) | Baseline, 12mths post treatment, and 24 mths post treatment | 
| Renal Function Change after SABR assessed by using eGFR | Estimated Glomular Filtration Rate (eGFR) | Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths |