TROG 13.01 SAFRON II Stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung: A randomised phase II trial

Funding

Government body,Cancer Australia

Scientific enquiries

A/Prof Shankar Siva

Brief Summary

This study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours. Who is it for? You may be eligible to join this study if; + you are aged 18 years or above + have 1-3 lung metastases from any non-haematological primary tumour + you are medically inoperable, high risk or have decline surgery + you have not had any previous high-dose radiotheradpy to the chest region Study details: SABR is an exciting novel radiotherapy tech .... This study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours. Who is it for? You may be eligible to join this study if; + you are aged 18 years or above + have 1-3 lung metastases from any non-haematological primary tumour + you are medically inoperable, high risk or have decline surgery + you have not had any previous high-dose radiotheradpy to the chest region Study details: SABR is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited lung metastases, SABR can result in long-term survival. It is non-invasive and associated with high rates of tumour control and relatively low toxicity. Additionally, the large doses of precision radiotherapy involved may evoke a strong immune response to recognise and attack any remaining tumour cells. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. Participants in this study will be randomly (by chance) allocated to receive either multi-fraction SABR (4 fractions over 2 weeks) or single fraction SABR (1 fraction only). All participants will be assessed at regular intervals post treatment in order to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR. The follow-up visits occur every 3 months in 1st year post treatment, then every 4 months in the second year and then 6 monthly until study closure (2 years after the last participant finishes study treatment).
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Key Inclusion Criteria

1) ECOG 0-1 inclusive 2) A maximum of three metastases to the lung from any non-haematological malignancy 3) Tumour diameter less than or equal to 5cm 4) Targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). Targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible. 5) Primary and extrathoracic disease controlled with local therapy (e.g. surgery/definitive radiotherapy) 6) Life expectanc .... 1) ECOG 0-1 inclusive 2) A maximum of three metastases to the lung from any non-haematological malignancy 3) Tumour diameter less than or equal to 5cm 4) Targets are located away from central structures (defined as 2cm beyond bifurcation of lobar bronchi and central airways). Targets in proximity to chest wall and mediastinum that meet these inclusion criteria are eligible. 5) Primary and extrathoracic disease controlled with local therapy (e.g. surgery/definitive radiotherapy) 6) Life expectancy greater than 9 months 7) Available for follow up for 2 years
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Key Exclusion Criteria

1) Previous high-dose thoracic radiotherapy 2) Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. 3) Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment 4) Germ cell and small cell carcinoma histologies