Cancer, Metastases to the Lung
Conditions
Keywords
Oligometastatic, Neoplasia, Radiosurgery, Stereotactic Ablative Body Radiotherapy, SABR, Metastases to the Lung, Non Haematological
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.
Interventions
RADIATIONMulti-fraction SABR
Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
RADIATIONSingle Fraction SABR
Single fraction SABR; 28Gy delivered in 1 fraction
Sponsors
Australasian Lung Cancer Trials Group
Trans Tasman Radiation Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. A maximum of three metastases to the lung from any non-haematological malignancy 2. Tumour diameter ≤5cm 3. 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. 4. Patients must be medically inoperable, technically high risk or have declined surgery.
Exclusion criteria
1. Previous high-dose thoracic radiotherapy. 2. 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) 3. Targeted agents (such as sunitinib and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival | 24 months | Overall survival assesed by 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immune response | 3 months | To explore immune system responses to single fraction and multi-fraction SABR. |
Countries
Australia
Outcome results
None listed