Cancer types
  • Urology
Title of study
Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney - A Phase II study
Version Number
Approval Date 
2, 12 December 2018
Short Title
Fastrack II
Study site
Principle Investigator
Prof. Shankar Siva
Investigator Maastro
Dr. B. Vanneste
Sponsor
MAASTRO
Trial registry
Objectives 

Primary Objective:
The primary objective of this study is to estimate the efficacy of SABR for primary RCC

Secondary Objectives:
• To estimate the tolerability of SABR for primary RCC
• To characterise overall survival
• To characterise cancer specific mortality after SABR
• To estimate the distant failure rate after SABR
• To describe renal function change after SABR
• To assess cost-effectiveness of SABR

Exploratory Objective
To explore multiparametric MRI as a biomarker of treatment response

Primary Endpoint 

Freedom from local progression, as defined by lack of progression of the target lesion (primary RCC) as measured by RECIST criteria [68]

Secondary Endpoints 

Secondary Endpoints:
• Toxicity, as measured by CTCAE v4.03
• Overall survival
• Cancer specific survival
• Freedom from distant failure
• Serum creatinine and estimated glomerular filtration rate (eGFR) using CKI-EPI equation, split function and calculated glomerular filtration rate (GFR) on nuclear medicine testing
• Assess the cost-effectiveness of SABR compared with alternative extirpative and ablative therapies

Exploratory Endpoint:
Change in Dynamic contrast enhanced (DCE) and Diffusion-weight imaging (DWI) parameters after SABR