Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial

Author(s): Prof Shankar Siva, MBBS PhD1,2; Mathias Bressel, MSc1,2; Mark Sidhom, MBBS3,4; Swetha Sridharan, MBBS5; Ben G L Vanneste, MD PhD6,7; Ryan Davey, PhD8; Rebecca Montgomery, BBiomedSc8; Jeremy Ruben, MbBCh9,10; Prof Farshad Foroudi, MBBS11; Braden Higgs, MBBS12,13; Charles Lin, MBBS14,15; Avi Raman, MBBS MPH16; Nicholas Hardcastle, PhD1,2; Prof Michael S Hofman, MBBS1,2; Richard De Abreu Lourenco, PhD17; Mark Shaw, MBChB1; Pascal Mancuso, MBBS18; Daniel Moon, MBBS1,19; Lih-Ming Wong, MBBS20; Nathan Lawrentschuk, MBBS PhD1,21; Simon Wood, MBBS22,23; Nicholas R Brook, MD24,25; Prof Tomas Kron, PhD1,2; Prof Jarad Martin, DMed PhD26; David Pryor, MBBS27,28
Anjan J Patel MD

Dr. Anjan Patel's Thoughts

Phase 2 study showing that SABR for RCC is safe and feasible for those who refuse or are not candidates for surgery. The median age was 77, and this seems to be a safe, noninvasive alternative.


Stereotactic ablative body radiotherapy (SABR) is a novel non-invasive alternative for patients with primary renal cell cancer who do not undergo surgical resection. The FASTRACK II clinical trial investigated the efficacy of SABR for primary renal cell cancer in a phase 2 trial.


This international, non-randomised, phase 2 study was conducted in seven centres in Australia and one centre in the Netherlands. Eligible patients aged 18 years or older had biopsy-confirmed diagnosis of primary renal cell cancer, with only a single lesion; were medically inoperable, were at high risk of complications from surgery, or declined surgery; and had an Eastern Cooperative Oncology Group performance status of 0–2. A multidisciplinary decision that active treatment was warranted was required. Key exclusion criteria were a pre-treatment estimated glomerular filtration rate of less than 30 mL/min per 1·73 m2, previous systemic therapies for renal cell cancer, previous high-dose radiotherapy to an overlapping region, tumours larger than 10 cm, and direct contact of the renal cell cancer with the bowel. Patients received either a single fraction SABR of 26 Gy for tumours 4 cm or less in maximum diameter, or 42 Gy in three fractions for tumours more than 4 cm to 10 cm in maximum diameter. The primary endpoint was local control, defined as no progression of the primary renal cell cancer, as evaluated by the investigator per Response Evaluation Criteria in Solid Tumours (version 1.1). Assuming a 1-year local control of 90%, the null hypothesis of 80% or less was considered not to be worthy of proceeding to a future randomised controlled trial. All patients who commenced trial treatment were included in the primary outcome analysis. This trial is registered with, NCT02613819, and has completed accrual.


Between July 28, 2016, and Feb 27, 2020, 70 patients were enrolled and initiated treatment. Median age was 77 years (IQR 70–82). Before enrolment, 49 (70%) of 70 patients had documented serial growth on initial surveillance imaging. 49 (70%) of 70 patients were male and 21 (30%) were female. Median tumour size was 4·6 cm (IQR 3·7–5·5). All patients enrolled had T1–T2a and N0–N1 disease. 23 patients received single-fraction SABR of 26 Gy and 47 received 42 Gy in three fractions. Median follow-up was 43 months (IQR 38–60). Local control at 12 months from treatment commencement was 100% (p<0·0001). Seven (10%) patients had grade 3 treatment-related adverse events, with no grade 4 adverse events observed. Grade 3 treatment-related adverse events were nausea and vomiting (three [4%] patients), abdominal, flank, or tumour pain (four [6%]), colonic obstruction (two [3%]), and diarrhoea (one [1%]). No treatment-related or cancer-related deaths occurred.


To our knowledge, this is the first multicentre prospective clinical trial of non-surgical definitive therapy in patients with primary renal cell cancer. In a cohort with predominantly T1b or larger disease, SABR was an effective treatment strategy with no observed local failures or cancer-related deaths. We observed an acceptable side-effect profile and renal function after SABR. These outcomes support the design of a future randomised trial of SABR versus surgery for primary renal cell cancer.


Cancer Australia Priority-driven Collaborative Cancer Research Scheme.

Author Affiliations

1Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; 2Sir Peter MacCallum Department of Oncology, University of Melbourne, VIC, Australia; 3Department of Radiation Oncology, Liverpool Hospital, Liverpool, NSW, Australia; 4South West Sydney Clinical School, University of New South Wales, Sydney, NSW, Australia; 5Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia; 6Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Reproduction, Maastricht University Medical Center, Maastricht, Netherlands; 7Department of Human Structure and Repair, Department of Radiation Oncology, Ghent University Hospital, Ghent, Belgium; 8TransTasman Radiation Oncology Group, Waratah, NSW, Australia; 9Department of Radiation Oncology, Alfred Health Radiation Oncology, Melbourne, VIC, Australia; 10Central Clinical School, Monash University, Melbourne, VIC, Australia; 11Department of Radiation Oncology, Olivia Newton-John Cancer Wellness and Research Centre, Heidelberg, VIC, Australia; 12Department of Radiation Oncology, Royal Adelaide Hospital, South Australia, Australia; 13Department of Radiation Oncology, University of South Australia, Adelaide, SA, Australia; 14Department of Radiation Oncology, Royal Brisbane and Women’s Hospital, QLD, Australia; 15University of Queensland, Brisbane, QLD, Australia; 16Department of Urology, John Hunter Hospital, Newcastle, NSW, AustraliaThe University of Newcastle, NSW, Australia; 17Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia; 18Department of Urology, Liverpool Hospital, Liverpool, NSW, Australia; 19Royal Melbourne Clinical School, University of Melbourne, VIC, Australia; 20Department of Surgery, University of Melbourne, VIC, AustraliaDepartment of Urology, St Vincent’s Health, Melbourne, VIC, Australia; 21Department of Surgery, University of Melbourne, VIC, Australia; 22University of Queensland, Brisbane, QLD, Australia; 23Department of Urology and Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; 24Department of Urology, Royal Adelaide Hospital, South Australia, Australia; 25Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia; 26Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, AustraliaThe University of Newcastle, NSW, Australia; 27Department of Urology and Radiation Oncology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia; 28Queensland University of Technology, Brisbane, QLD, Australia

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