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Trial registered on ANZCTR


Registration number
ACTRN12613001157763
Ethics application status
Approved
Date submitted
14/10/2013
Date registered
17/10/2013
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
Scientific title
A Randomised Phase II Trial to Evaluate the Toxicity, Quality of Life, Clinical Efficacy and Cost Effectiveness of Stereotactic Ablative Fractionated Radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (SAFRON II)
Secondary ID [1] 282585 0
NCT01965223 - ClinicalTrials.gov
Secondary ID [2] 286695 0
ALTG 13.001
Secondary ID [3] 286696 0
TROG 13.01
Universal Trial Number (UTN)
1111-1136-6607
Trial acronym
SAFRON II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oligometastatic Neoplasia to the Lung (from any non-haematological malignancy) 289276 0
Condition category
Condition code
Cancer 289600 289600 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Multi-fraction Stereotactic Ablative Body Radiation (SABR); 48Gy delivered in 4 fractions over 2 weeks, with a minimum of 48 hours between each fraction.
Intervention code [1] 287251 0
Treatment: Devices
Comparator / control treatment
Single fraction SABR (also known as radiosurgery); 28Gy delivered in 1 fraction.
Control group
Active

Outcomes
Primary outcome [1] 289692 0
The primary outcome is safety, defined as number of participants experiencing less than or equal to 5% toxicity at 12 months post treatment (toxicity measured by CTCAE V4).
Timepoint [1] 289692 0
12 months post treatment
Secondary outcome [1] 303030 0
Quality of life outcomes between techniques assesed using EQ-5DL and MDASI-LC.
Timepoint [1] 303030 0
24 months
Secondary outcome [2] 303031 0
Local progression free survival assesed by CT scan and clinical assesment
Timepoint [2] 303031 0
24 months post treatment
Secondary outcome [3] 303032 0
Overall survival assesed by clinical assesment
Timepoint [3] 303032 0
24 months post treatment
Secondary outcome [4] 303033 0
Time to distant failure assesed by CT scan and clinical assesment
Timepoint [4] 303033 0
24 months post treatment
Secondary outcome [5] 303034 0
Resources use and costs associated with treatment assesed EQ5DL and by MBS/PBS data
Timepoint [5] 303034 0
24 months post treatment

Eligibility
Key inclusion criteria
1) ECOG 0-1 inclusive
2) A maximum of three metastases to the lung from any non-haematological malignancy
3) Tumour diameter less than or equal to 5cm
4) 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.
5) Primary and extrathoracic disease controlled with local therapy (e.g. surgery/definitive radiotherapy)
6) Life expectancy greater than 9 months
7) Available for follow up for 2 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Previous high-dose thoracic radiotherapy
2) Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment.
3) Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment
4) Germ cell and small cell carcinoma histologies

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 3786 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 3787 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 3788 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 3789 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 4131 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [6] 6494 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 6495 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [8] 8518 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [9] 8519 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 8520 0
Peter Maccallum Cancer Centre - Moorabbin Campus - Bentleigh East
Recruitment hospital [11] 10219 0
The Canberra Hospital - Garran
Recruitment hospital [12] 10220 0
Prince of Wales Hospital - Randwick
Recruitment hospital [13] 10221 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [14] 10222 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [15] 10223 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 9667 0
1871 - Liverpool
Recruitment postcode(s) [2] 21749 0
2031 - Randwick
Recruitment postcode(s) [3] 14059 0
2065 - St Leonards
Recruitment postcode(s) [4] 10062 0
2298 - Waratah
Recruitment postcode(s) [5] 21750 0
2560 - Campbelltown
Recruitment postcode(s) [6] 21748 0
2605 - Garran
Recruitment postcode(s) [7] 9670 0
3002 - East Melbourne
Recruitment postcode(s) [8] 16611 0
3084 - Heidelberg
Recruitment postcode(s) [9] 16613 0
3165 - Bentleigh East
Recruitment postcode(s) [10] 21752 0
3350 - Ballarat Central
Recruitment postcode(s) [11] 21751 0
4029 - Herston
Recruitment postcode(s) [12] 9668 0
4102 - Woolloongabba
Recruitment postcode(s) [13] 9669 0
5000 - Adelaide
Recruitment postcode(s) [14] 16612 0
6009 - Nedlands
Recruitment postcode(s) [15] 14058 0
7000 - Hobart
Recruitment outside Australia
Country [1] 5117 0
New Zealand
State/province [1] 5117 0

Funding & Sponsors
Funding source category [1] 291264 0
Government body
Name [1] 291264 0
Cancer Australia
Address [1] 291264 0
Level 14, 300 Elizabeth Street, Surry Hills NSW 2010
Country [1] 291264 0
Australia
Funding source category [2] 294330 0
Charities/Societies/Foundations
Name [2] 294330 0
Auckland Medical Research Foundation
Address [2] 294330 0
Ground Floor, 89 Grafton Road
P O Box 110139, Auckland Hospital
Auckland 1148
Country [2] 294330 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Trans Tasman Radiation Oncology Group (TROG)
Address
TROG Central Office
PO Box 88
Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 286111 0
None
Name [1] 286111 0
Address [1] 286111 0
Country [1] 286111 0
Other collaborator category [1] 277438 0
Other Collaborative groups
Name [1] 277438 0
Australasian Lung Trials Group
Address [1] 277438 0
The Australian Lung Foundation
44 Brookes Street
Bowen Hills, QLD 4006
Country [1] 277438 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289341 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 289341 0
Ethics committee country [1] 289341 0
Australia
Date submitted for ethics approval [1] 289341 0
01/12/2013
Approval date [1] 289341 0
12/05/2014
Ethics approval number [1] 289341 0

Summary
Brief summary
This study is evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of lung tumours.

Who is it for?
You may be eligible to join this study if;
+ you are aged 18 years or above
+ have 1-3 lung metastases from any non-haematological primary tumour
+ you are medically inoperable, high risk or have decline surgery
+ you have not had any previous high-dose radiotheradpy to the chest region

Study details:
SABR is an exciting novel radiotherapy technique that is delivered over very few sessions. In the case of limited lung metastases, 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. There are two SABR techniques emerging in Australia; fractionated and single fraction treatments.
Participants in this study will be randomly (by chance) allocated to receive either multi-fraction SABR (4 fractions over 2 weeks) or single fraction SABR (1 fraction only).
All participants will be assessed at regular intervals post treatment in order to evaluate the toxicity, Quality of Life, clinical efficacy and cost effectiveness of single fraction SABR compared to multi-fraction SABR.
The follow-up visits occur every 3 months in 1st year post treatment, then every 4 months in the second year and then 6 monthly until study closure (2 years after the last participant finishes study treatment).
Trial website
http://trog.com.au/TROG-1301-SAFRON-II
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40386 0
A/Prof Shankar Siva
Address 40386 0
Peter MacCallum Cancer Centre,
Locked Bag 1
A'Beckett St
Melbourne, 8006
VIC
Country 40386 0
Australia
Phone 40386 0
+61 3 9656 1111
Fax 40386 0
Email 40386 0
shankar.siva@petermac.org
Contact person for public queries
Name 40387 0
Ms Brita Lehmann
Address 40387 0
TROG Central Office
PO Box 88
Waratah NSW 2298
Country 40387 0
Australia
Phone 40387 0
+61 2 401 43912
Fax 40387 0
Email 40387 0
SAFRONII@trog.com.au
Contact person for scientific queries
Name 40388 0
A/Prof Shankar Siva
Address 40388 0
Peter MacCallum Cancer Centre,
Locked Bag 1
A'Beckett St
Melbourne, 8006
VIC
Country 40388 0
Australia
Phone 40388 0
+61 3 9656 1111
Fax 40388 0
Email 40388 0
shankar.siva@petermac.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary