Author of

• 18739

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  P3.06 - Poster Session with Presenters Present (ID 492)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Trial Design/Statistics
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18742

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    P3.06-003 - SARON: Stereotactic Ablative Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer (NSCLC). A UK Randomised Phase III Trial (ID 3814)

    14:30 - 14:30  |  Author(s): L. Farrelly
    • Abstract
    • Slides

    Background:
    It has been theorised that local ablative therapy such as stereotactic ablative radiotherapy (SABR) and stereotactic radiosurgery (SRS) could improve outcomes for patients with oligometastatic disease. There is now growing evidence to support the safety, local control effect and potential improvement in overall survival (OS) for SABR/SRS to warrant a randomised phase III trial. The SARON trial investigates the impact on OS of radiotherapy (RT) plus SABR/SRS following standard chemotherapy in patients with oligometastatic NSCLC and will undertake an early evaluation of feasibility and toxicity.
    
    Methods:
    SARON is a randomised, multicentre, phase III trial for patients with oligometastatic NSCLC (1-3 sites of synchronous metastatic disease). An early feasibility review will take place after 50 randomised patients. Patients requiring both conventional thoracic RT to the primary and SABR to a thoracic metastasis will be included in a sub-study to more thoroughly assess toxicity and planning issues. 340 patients will be recruited from 30 UK sites, to randomise 306 patients (1:1) to receive either platinum doublet chemotherapy alone (control arm) or platinum doublet chemotherapy followed by radical RT/SABR to their primary tumour and then SABR and/or SRS to all other metastatic sites (investigational arm). Figure 1
    
    
    
    Results:
    The primary endpoint is OS, and the study is powered to detect an improvement in median survival from 9.9 months in the control arm to 14.3 months in the investigational arm (85% power, 5% two-sided alpha). The secondary endpoints include progression free survival, toxicity, local control of primary and metastases, and quality of life.
    
    Conclusion:
    The study will open in Q3 2016 and is supported by Cancer Research UK (C13530/A18015).
    
    

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