Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial

A Randomised Phase II Trial to Evaluate the Toxicity, Quality of Life, Clinical Efficacy and Cost Effectiveness of Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (SAFRON II)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001157763

Acronym

SAFRON II

Enrollment

Registered

2013-10-17

Start date

2015-02-04

Completion date

2018-06-13

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 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).

Interventions

Multi-fraction Stereotactic Ablative Body Radiation (SABR); 48Gy delivered in 4 fractions over 2 weeks, with a minimum of 48 hours between each fraction.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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 expectancy greater than 9 months 7) Available for follow up for 2 years

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

Outcome results