TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II

Stereotactic ablative body radiotherapy (SABR) is a non-invasive alternative to surgery to control primary renal cell cancer (RCC) in patients that are medically inoperable or at high-risk of post-surgical dialysis. The objective of the FASTRACK II clinical trial is to investigate the efficacy of SABR for primary RCC.

FASTRACK II is a single arm, multi-institutional phase II study. Seventy patients will be recruited over 3 years and followed for a total of 5 years. Eligible patients must have a biopsy confirmed diagnosis of primary RCC with a single lesion within a kidney, have ECOG performance ≤2 and be medically inoperable, high risk or decline surgery. Radiotherapy treatment planning is undertaken using four dimensional CT scanning to incorporate the impact of respiratory motion. Treatment must be delivered using a conformal or intensity modulated technique including IMRT, VMAT, Cyberknife or Tomotherapy. The trial includes two alternate fractionation schedules based on tumour size: for tumours ≤4 cm in maximum diameter a single fraction of 26Gy is delivered; and for tumours > 4 cm in maximum diameter 42Gy in three fractions is delivered. The primary outcome of the study is to estimate the efficacy of SABR for primary RCC. Secondary objectives include estimating tolerability, characterising overall survival and cancer specific survival, estimating the distant failure rate, describing toxicity and renal function changes after SABR, and assessment of cost-effectiveness of SABR compared with current therapies.

The present study design allows for multicentre prospective validation of the efficacy of SABR for primary RCC that has been observed from prior single institutional and retrospective series. The study also allows assessment of treatment related toxicity, overall survival, cancer specific survival, freedom from distant failure and renal function post therapy. NCT02613819 , registered Nov 25th 2015.

BMC cancer. 2018 Oct 23*** epublish ***

Shankar Siva, Brent Chesson, Mathias Bressel, David Pryor, Braden Higgs, Hayley M Reynolds, Nicholas Hardcastle, Rebecca Montgomery, Ben Vanneste, Vincent Khoo, Jeremy Ruben, Eddie Lau, Michael S Hofman, Richard De Abreu Lourenco, Swetha Sridharan, Nicholas R Brook, Jarad Martin, Nathan Lawrentschuk, Tomas Kron, Farshad Foroudi

Peter MacCallum Cancer Centre, 305 Grattan Street Melbourne, Melbourne, 3000, Australia. ., Peter MacCallum Cancer Centre, 305 Grattan Street Melbourne, Melbourne, 3000, Australia., Princess Alexandra Hospital, Brisbane, QLD, Australia., University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia., Trans Tasman Radiation Oncology Group (TROG), Waratah, Australia., MAASTRO Clinic, Maastricht, The Netherlands., Royal Marsden Hospital, London, UK., Alfred Health and Monash University, 55 Commercial Rd, Melbourne, 3004, Australia., Austin Health, Heidelberg, 3084, Australia., Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia., Calvary Mater Newcastle, Newcastle, NSW, Australia., Radiation Oncology, Austin Health, Heidelberg, Australia.