A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)
- Conditions
- CancerMetastases to the Lung
- Interventions
- Radiation: Multi-fraction SABRRadiation: Single Fraction SABR
- Registration Number
- NCT01965223
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- Brief Summary
The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.
- Detailed Description
Stereotactic Ablative Body Radiotherapy (SABR) is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited pulmonary 'oligometastases', 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. In the future, SABR may be an attractive alternative to invasive surgery. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments. We aim to conduct the first clinical trial of SABR in patients with limited pulmonary metastases testing fractionated versus single fraction treatments.
The primary aim of this study is to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR in patients with oligometastases to the lung.
The secondary aim of this study is to assess the immune response evoked by both fractionated and single fraction SABR and its prognostic implications for patient outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- A maximum of three metastases to the lung from any non-haematological malignancy
- Tumour diameter ≤5cm
- 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.
- Patients must be medically inoperable, technically high risk or have declined surgery.
- Previous high-dose thoracic radiotherapy.
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are not excluded (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotrophin releasing hormone receptor modulators)
- Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-fraction SABR Multi-fraction SABR Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart. Single fraction SABR Single Fraction SABR Radiotherapy: 28Gy delivered in 1 fraction
- Primary Outcome Measures
Name Time Method Toxicity 12 months The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity as measured by CTCAE V4).
- Secondary Outcome Measures
Name Time Method Quality of Life 24 months To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.
Time to local failure 24 months Local progression free survival assesed by CT scan and clinical assessment
Disease Free Survival 24 months Disease free survival will be measured from the date of randomisation to the date of a local recurrence, regional or distant metastasis, or death from any cause, whichever occurs first.
Time to distant failure 24 months Time to distant failure assessed by CT scan and clinical assessment
Resources use and costs associated with treatment 24 months Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data
Overall survival 24 months Overall survival assesed by clinical assessment
Trial Locations
- Locations (9)
Cambelltown Hospital
🇦🇺Sydney, New South Wales, Australia
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Northern Sydney Cancer Centre (RNS)
🇦🇺St Leonards, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Peter MacCallum Cancer Center
🇦🇺Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Calvary Mater Hospital
🇦🇺Newcastle, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia