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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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)
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Scientific title
Stereotactic Ablative Fractionated Radiotherapy Versus Radiosurgery for Oligometastatic Neoplasia to the Lung: A Randomised Phase II Trial
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Secondary ID [1]
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TROG 13.01
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Secondary ID [2]
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TROG 13.01
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Universal Trial Number (UTN)
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Trial acronym
SAFRON II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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Metastases to the Lung
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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0
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0
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Lung - Non small cell
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Cancer
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Toxicity
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Assessment method [1]
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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).
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Quality of Life
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Assessment method [1]
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To compare quality of life outcomes between techniques assessed using EQ-5DL and MDASI-LC questionnaires.
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Time to local failure
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Assessment method [2]
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Local progression free survival assesed by CT scan and clinical assessment
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Overall survival
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Assessment method [3]
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Overall survival assesed by clinical assessment
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Time to distant failure
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Assessment method [4]
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Time to distant failure assessed by CT scan and clinical assessment
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Resources use and costs associated with treatment
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Assessment method [5]
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Resources use and costs associated with treatment assessed by EQ5DL and accessing Medicare data
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Timepoint [5]
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24 months
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Secondary outcome [6]
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Disease Free Survival
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Assessment method [6]
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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.
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Timepoint [6]
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24 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/07/2020
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Sample size
Target
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Accrual to date
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Final
90
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Calvary Mater Hospital - Newcastle
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Northern Sydney Cancer Centre (RNS) - St Leonards
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Recruitment hospital [5]
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Cambelltown Hospital - Sydney
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [8]
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Peter MacCallum Cancer Center - Melbourne
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Recruitment hospital [9]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2298 - Newcastle
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2065 - St Leonards
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Recruitment postcode(s) [5]
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2560 - Sydney
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Recruitment postcode(s) [6]
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4102 - Woolloongabba
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment postcode(s) [8]
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3002 - Melbourne
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Recruitment postcode(s) [9]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Other
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Name
Trans Tasman Radiation Oncology Group
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australasian Lung Cancer Trials Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01965223
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Trial related presentations / publications
Siva 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.
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Public notes
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Contacts
Principal investigator
Name
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Shankar Siva
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Address
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Peter MacCallum Cancer Centre, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01965223
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