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ALTG 13/001 TROG 13.01 SAFRON II: Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial – S Siva

This trial aims to evaluate single fraction SABR (28Gy/1) versus fractionated SABR (48Gy/4) in a randomised phase II trial of 84 patients. This study aims to assess safety of the two techniques and to compare quality of life outcomes, clinical efficacy and the resource usage and costs associated of each technique. This study also aims to establish a fully annotated trial-related bank of blood and pre-treatment tissue for future analysis.

The major inclusion criteria are;

  • A maximum of three metastases to the lung from any non-haematological malignancy
  • Tumour diameter ≤5cm
  • ECOG 0 or 1
  • Targets located away from central targets
  • Primary and extrathoracic disease controlled with local therapy
  • Major exclusion criteria are;
  • Previous high-dose thoracic radiotherapy in the region of proposed SABR
  • Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment
  • Concurrent targeted agents (such as sunitinib, bevacizumab and tarceva).
  • Germ cell and small cell histologies

This study has accrued 48 participants. Open centres include Calvary Mater Newcastle, Campbelltown Hospital, Canberra Hospital, Liverpool Hospital, Peter MacCallum Cancer Centre, Prince of Wales Hospital, Princess Alexandra Hospital, Royal Adelaide Hospital, Royal Hobart Hospital and Royal North Shore Hospital.

Publications

Pham D, Hardcastle N, Foroudi F, Kron T, Bressel M, Hilder B, Chesson B, Oates R, Montgomery R, Ball D, Siva S. A Multidisciplinary Evaluation of a Web-based eLearning Training Programme for SAFRON II (TROG 13.01): A Multicentre Randomised Study of Stereotactic Radiotherapy for Lung Metastases. Clin Oncol. 2016 Sep; 28(9):e101-08.

Siva S, Kron T, Bressel M, Haas M, Mai T, Vinod S, Sasso G, Wong W, Le H, Eade T, Hardcastle N, Chesson B, Pham D, Høyer M, Montgomery R, Ball D. A Randomised Phase II Trial of Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the Lung (TROG 13.01 SAFRON II). BMC Cancer. 2016 Mar: 16:183

Study Contacts
Trial Chair: Dr Shankar Siva, Peter MacCallum Cancer Centre shankar.siva@petermac.org
Trial Co-ordinator: Rebecca Montgomery, TROG Cancer Research SAFRONII@trog.com.au