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Title: TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II.
Austin Authors: Siva, Shankar;Chesson, Brent;Bressel, Mathias;Pryor, David;Higgs, Braden;Reynolds, Hayley M;Hardcastle, Nicholas;Montgomery, Rebecca;Vanneste, Ben;Khoo, Vincent;Ruben, Jeremy;Lau, Eddie ;Hofman, Michael S;De Abreu Lourenco, Richard;Sridharan, Swetha;Brook, Nicholas R;Martin, Jarad;Lawrentschuk, Nathan;Kron, Tomas;Foroudi, Farshad 
Affiliation: Princess Alexandra Hospital, Brisbane, QLD, Australia
Calvary Mater Newcastle, Newcastle, NSW, Australia
Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia
Austin Health, Heidelberg, Victoria, Australia
Alfred Health and Monash University, 55 Commercial Rd, Melbourne, 3004, Australia
University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre, 305 Grattan Street Melbourne, Melbourne, 3000, Australia
University of Melbourne, Royal Parade, Parkville, 8006, Australia
Department of Radiation Oncology, Austin Health, Heidelberg, Victoria, Australia
Trans Tasman Radiation Oncology Group (TROG), Waratah, Australia
MAASTRO Clinic, Maastricht, The Netherlands
Royal Marsden Hospital, London, UK
Issue Date: 23-Oct-2018 2018-10-23
Publication information: BMC cancer 2018; 18(1): 1030
Abstract: 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.
DOI: 10.1186/s12885-018-4916-2
ORCID: 0000-0003-2840-0658
Journal: BMC cancer
PubMed URL: 30352550
Type: Journal Article
Subjects: Ablation
Appears in Collections:Journal articles

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