title: A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II).
abstract: BACKGROUND
  Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases.
  
  
  METHODS
  The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study.
  
  
  CONCLUSIONS
  Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR.
  
  
  BACKGROUND
  ACTRN12613001157763 , registered 17th October 2013.
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. shankar.siva@petermac.org.|University of Melbourne, Royal Parade, Parkville, 8006, Australia. shankar.siva@petermac.org.
authors.forename: Shankar
authors.initials: S
authors.lastname: Siva
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. tomas.kron@petermac.org.|University of Melbourne, Royal Parade, Parkville, 8006, Australia. tomas.kron@petermac.org.
authors.forename: Tomas
authors.initials: T
authors.lastname: Kron
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. mathias.bressel@petermac.org.
authors.forename: Mathias
authors.initials: M
authors.lastname: Bressel
authors.affiliation: Centre for Health Economics Research and Evaluation, University of Technology Sydney, PO Box 123, Broadway Sydney, 2007, Australia. marion.haas@chere.uts.edu.au.
authors.forename: Marion
authors.initials: M
authors.lastname: Haas
authors.affiliation: Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld, 4102, Australia. Tao.Mai@health.qld.gov.au.
authors.forename: Tao
authors.initials: T
authors.lastname: Mai
authors.affiliation: Cancer Therapy Centre, Liverpool Hospital, Locked Bag 7103, Liverpool BC, NSW, 1871, Australia. shalini.vinod@sswahs.nsw.gov.au.
authors.forename: Shalini
authors.initials: S
authors.lastname: Vinod
authors.affiliation: Radiation Oncology Department, Auckland City Hospital, Auckland, New Zealand. GSasso@adhb.govt.nz.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sasso
authors.affiliation: Department of Radiation Oncology, Prince of Wales Hospital, Barker St, Randwick, NSW, 2031, Australia. wenchang.wong@sesiahs.health.nsw.gov.au.
authors.forename: Wenchang
authors.initials: W
authors.lastname: Wong
authors.affiliation: Department of Radiation Oncology, Royal Adelaide Hospital, North Terrace, Adelaide, SA, 5000, Australia. hien.le@sa.gov.au.
authors.forename: Hien
authors.initials: H
authors.lastname: Le
authors.affiliation: Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards, 2065, NSW, Australia. Thomas.eade@health.nsw.gov.au.
authors.forename: Thomas
authors.initials: T
authors.lastname: Eade
authors.affiliation: Department of Radiation Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, St Leonards, 2065, NSW, Australia. nicholas.hardcastle@health.nsw.gov.au.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Hardcastle
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. brent.chesson@petermac.org.
authors.forename: Brent
authors.initials: B
authors.lastname: Chesson
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. danieljpham@gmail.com.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pham
authors.affiliation: Department of Oncology, Aarhus University Hospital, Aarhus, 8000, Denmark. hoyer@aarhus.rm.dk.
authors.forename: Morten
authors.initials: M
authors.lastname: Høyer
authors.affiliation: Trans Tasman Radiation Oncology Group (TROG), PO Box 88, Waratah, 2298, Australia. rebecca.montgomery@trog.com.au.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Montgomery
authors.affiliation: Peter MacCallum Cancer Centre, 2 St Andrews Place, East Melbourne, 3002, Australia. david.ball@petermac.org.|University of Melbourne, Royal Parade, Parkville, 8006, Australia. david.ball@petermac.org.
authors.forename: David
authors.initials: D
authors.lastname: Ball
mesh_terms: D019583:Dose Fractionation, Radiation; D017048:Health Care Costs; D006295:Health Resources; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000556:secondary* / Q000628:therapy*; D011788:Quality of Life; D016634:Radiosurgery / Q000191:economics / Q000379:methods; D011878:Radiotherapy / Q000191:economics / Q000379:methods*; D014057:Tomography, X-Ray Computed; D047368:Tumor Burden