Trial from ClinicalTrials.gov

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



Trial ID
NCT01965223
Ethics application status
Date submitted
13/10/2013
Date registered
13/10/2013
Date last updated
17/11/2016

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
Radiation - Multi-fraction SABR
Radiation - 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


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

Radiation: 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 - 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).
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of Life - To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Time to local failure - Local progression free survival assesed by CT scan and clinical assessment
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Overall survival - Overall survival assesed by clinical assessment
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Time to distant failure - Time to distant failure assessed by CT scan and clinical assessment
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Resources use and costs associated with treatment - Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
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.
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
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. 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
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Actual
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Cambelltown Hospital - Cambelltown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Calvary Mater Hospital - Newcastle
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 0 0
Northern Sydney Cancer Centre (RNS) - St Leonards
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
2560 - Cambelltown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2298 - Newcastle
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
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 (TROG)
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/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
Shankar Siva
Address 0 0
Country 0 0
Phone 0 0
+61 3 9656 1111
Fax 0 0
Email 0 0
shankar.siva@petermac.org
Contact person for scientific queries
Contact person responsible for updating information