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

Brief Summary

Detailed Description

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).

Primary Outcomes

Secondary Outcomes

• Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4(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(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(Baseline, 12mths post treatment, and 24 mths post treatment)
• Renal Function Change after SABR assessed by using eGFR(Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths)