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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01965223




Registration number
NCT01965223
Ethics application status
Date submitted
13/10/2013
Date registered
18/10/2013
Date last updated
4/11/2020

Titles & IDs
Public title
A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)
Scientific title
Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
Secondary ID [1] 0 0
TROG 13.01
Secondary ID [2] 0 0
TROG 13.01
Universal Trial Number (UTN)
Trial acronym
SAFRON II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Metastases to the Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Multi-fraction SABR
Treatment: Other - Single Fraction SABR

Experimental: Multi-fraction SABR - Radiotherapy: 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Experimental: Single fraction SABR - Radiotherapy: 28Gy delivered in 1 fraction


Treatment: Other: Multi-fraction SABR
Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.

Treatment: Other: Single Fraction SABR
Single fraction SABR; 28Gy delivered in 1 fraction
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Toxicity
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of Life
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Time to local failure
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Time to distant failure
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Resources use and costs associated with treatment
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Disease Free Survival
Timepoint [6] 0 0
24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
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. 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.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/07/2020
Sample size
Target
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Northern Sydney Cancer Centre (RNS) - St Leonards
Recruitment hospital [5] 0 0
Cambelltown Hospital - Sydney
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Peter MacCallum Cancer Center - Melbourne
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2298 - Newcastle
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
2560 - Sydney
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3002 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Trans Tasman Radiation Oncology Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Lung Cancer Trials Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01965223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shankar Siva
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01965223