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 study is conducted under the auspices of the Trans Tasman Radiation Oncology Group (TROG). 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. Further centres (Sir Charles Gairdner, Austin Health, Auckland City Hospital, Royal Brisbane Women’s and Children’s Hospital) are expected to be activated in 2017.
Study accrual is 54 participants (30/03/2016), with accrual expected to be completed in July 2018.
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