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
Stereotactic Ablative Body Radiotherapy (SABR) is an emerging radiotherapy technique that is delivered over very few sessions. It is non-invasive and associated with high rates of tumour control and relatively low toxicity for patients with limited metastatic disease to the lung. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments.
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 pretreatment tissue for future analysis.
This is a Trans-Tasman Radiation Oncology Group (TROG) lead trial conducted in co-operation with the Australasian Lung Cancer Trials Group (ALTG).
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 opened in January 2015 and has accrued 11 participants. Open centres include Calvary Mater Newcastle, Liverpool Hospital, Peter MacCallum Cancer, Princess Alexandra Hospital and Royal Adelaide Hospital. Austin Health, Barwon Health, Campbelltown Hospital, Prince of Wales Hospital and Royal Hobart Hospital are all expected to be activated by the end of 2015.