A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)
SAFRON II
Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
3 other identifiers
interventional
90
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Feb 2015
Longer than P75 for not_applicable cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedStudy Start
First participant enrolled
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2020
CompletedNovember 4, 2020
November 1, 2020
5.5 years
October 13, 2013
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Quality of Life
24 months
Time to local failure
24 months
Overall survival
24 months
Time to distant failure
24 months
Resources use and costs associated with treatment
24 months
- +1 more secondary outcomes
Other Outcomes (1)
Immune response
3 months
Study Arms (2)
Multi-fraction SABR
EXPERIMENTALRadiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
Single fraction SABR
EXPERIMENTALRadiotherapy: 28Gy delivered in 1 fraction
Interventions
Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
Eligibility Criteria
You may qualify if:
- A maximum of three metastases to the lung from any non-haematological malignancy
- Tumour diameter ≤5cm
- Patients must be medically inoperable, technically high risk or have declined surgery.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Calvary Mater Hospital
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
Related Publications (2)
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.
PMID: 37179526DERIVEDSiva 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: 34455431DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Shankar Siva
Peter MacCallum Cancer Centre, Australia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2013
First Posted
October 18, 2013
Study Start
February 4, 2015
Primary Completion
July 27, 2020
Study Completion
July 27, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11