SAFRON II
ACTRN12613001157763
Treatment
Phase 2
Government body,Cancer Australia
A/Prof Shankar Siva
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 .... Read more
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 .... Read more
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
No
Sample Size 90
Min. age 18 Years
Max. age 0 No limit
Sex Both males and females
Condition category Oligometastatic Neoplasia to the Lung (from any non-haematological malignancy)
Condition code Cancer
Intervention code Treatment: Devices
Multi-fraction Stereotactic Ablative Body Radiation (SABR); 48Gy delivered in 4 fractions over 2 weeks, with a minimum of 48 hours between each fraction.
Control group Active
Single fraction SABR (also known as radiosurgery); 28Gy delivered in 1 fraction.
Outcome: The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity measured by CTCAE V4).Timepoint: 12 months post treatment
No