Clinical trial · Interventional
A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)
Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
NCT01965223CI-TRIAL-00048106SAFRON IIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastases to the Lung | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-fraction SABR | Radiation | — | UNRESOLVED |
| Single Fraction SABR | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Multi-fraction SABR
- description
- Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
- interventionNames
- Radiation: Multi-fraction SABR
- type
- EXPERIMENTAL
- label
- Single fraction SABR
- description
- Radiotherapy: 28Gy delivered in 1 fraction
- interventionNames
- Radiation: Single Fraction SABR
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDSiva 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. PMID 37179526
- DERIVEDSiva 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. PMID 34455431