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| ID | Type | Description | Link |
|---|---|---|---|
| TROG 13.01 | Other Identifier | Trans Tasman Radiation Oncology Group | |
| 13001 | Other Identifier | Australasian Lung Trials Group | |
| 1111-1136-6607 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Australasian Lung Cancer Trials Group | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-fraction SABR | Experimental | Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart. |
|
| Single fraction SABR | Experimental | Radiotherapy: 28Gy delivered in 1 fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-fraction SABR | Radiation | Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires. | 24 months |
| Time to local failure | Local progression free survival assesed by CT scan and clinical assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response | To explore immune system responses to single fraction and multi-fraction SABR. | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shankar Siva | Peter MacCallum Cancer Centre, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| Calvary Mater Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37179526 | Derived | Siva S, Sakyanun P, Mai T, Wong W, Lim A, Ludbrook J, Bettington C, Rezo A, Pryor D, Hardcastle N, Kron T, Higgs B, Le H, Skala M, Gill S, Eade T, Awad R, Sasso G, Vinod S, Montgomery R, Ball D, Bressel M. Long-Term Outcomes of TROG 13.01 SAFRON II Randomized Trial of Single- Versus Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases. J Clin Oncol. 2023 Jul 1;41(19):3493-3498. doi: 10.1200/JCO.23.00150. Epub 2023 May 14. | |
| 34455431 |
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| Single Fraction SABR | Radiation | Single fraction SABR; 28Gy delivered in 1 fraction |
|
| 24 months |
| Overall survival | Overall survival assesed by clinical assessment | 24 months |
| Time to distant failure | Time to distant failure assessed by CT scan and clinical assessment | 24 months |
| Resources use and costs associated with treatment | Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data | 24 months |
| Disease Free Survival | 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. | 24 months |
| Newcastle |
| New South Wales |
| 2298 |
| Australia |
| Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia |
| Northern Sydney Cancer Centre (RNS) | St Leonards | New South Wales | 2065 | Australia |
| Cambelltown Hospital | Sydney | New South Wales | 2560 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Peter MacCallum Cancer Center | Melbourne | Victoria | 3002 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Derived |
| Siva S, Bressel M, Mai T, Le H, Vinod S, de Silva H, Macdonald S, Skala M, Hardcastle N, Rezo A, Pryor D, Gill S, Higgs B, Wagenfuehr K, Montgomery R, Awad R, Chesson B, Eade T, Wong W, Sasso G, De Abreu Lourenco R, Kron T, Ball D, Neeson P; Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung (SAFRON) II Study Investigators. Single-Fraction vs Multifraction Stereotactic Ablative Body Radiotherapy for Pulmonary Oligometastases (SAFRON II): The Trans Tasman Radiation Oncology Group 13.01 Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1476-1485. doi: 10.1001/jamaoncol.2021.2939. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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