CompletedPhase 2ACTRN12613001157763

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)


Sponsor

Trans Tasman Radiation Oncology Group (TROG)

Enrollment

90 participants

Start Date

Feb 4, 2015

Study Type

Interventional

Conditions

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).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

  • ECOG 0-1 inclusive
  • A maximum of three metastases to the lung from any non-haematological malignancy
  • Tumour diameter less than or equal to 5cm
  • Primary and extrathoracic disease controlled with local therapy (e.g. surgery/definitive radiotherapy)
  • Life expectancy greater than 9 months
  • Available for follow up for 2 years

Exclusion Criteria4

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

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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.

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


Locations(16)

Peter MacCallum Cancer Institute - East Melbourne

NSW,QLD,SA,TAS,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,SA,TAS,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,TAS,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,TAS,VIC, Australia

Calvary Mater Newcastle - Waratah

NSW,QLD,SA,TAS,VIC, Australia

Royal Hobart Hospital - Hobart

NSW,QLD,SA,TAS,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,TAS,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,QLD,SA,TAS,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

NSW,QLD,SA,TAS,VIC, Australia

Peter Maccallum Cancer Centre - Moorabbin Campus - Bentleigh East

NSW,QLD,SA,TAS,VIC, Australia

The Canberra Hospital - Garran

NSW,QLD,SA,TAS,VIC, Australia

Prince of Wales Hospital - Randwick

NSW,QLD,SA,TAS,VIC, Australia

Campbelltown Hospital - Campbelltown

NSW,QLD,SA,TAS,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,TAS,VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

NSW,QLD,SA,TAS,VIC, Australia

New Zealand

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ACTRN12613001157763