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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02514512




Registration number
NCT02514512
Ethics application status
Date submitted
12/07/2015
Date registered
3/08/2015

Titles & IDs
Public title
Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking
Scientific title
Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
Secondary ID [1] 0 0
HREC/15/HAWKE/55
Universal Trial Number (UTN)
Trial acronym
LIGHTSABR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Lung Neoplasms 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: Devices - MLC Tracking

No intervention: Standard SABR - Patients receive standard treatment

Experimental: MLC Tracking SABR - Patients are treated with MLC tracking


Treatment: Devices: MLC Tracking
Treat patient with Non FDA approved MLC Tracking
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To demonstrate feasibility of MLC tracking for lung cancer
Timepoint [1] 0 0
Assessed at 2 years
Secondary outcome [1] 0 0
Audio Visual (AV) Biofeedback
Timepoint [1] 0 0
Assessed at 2 years
Secondary outcome [2] 0 0
Coefficient of variation in breathing patterns
Timepoint [2] 0 0
Assessed at 2 years
Secondary outcome [3] 0 0
Target volumes
Timepoint [3] 0 0
Assessed at 2 years
Secondary outcome [4] 0 0
Lung dose
Timepoint [4] 0 0
Assessed at 2 years
Secondary outcome [5] 0 0
Treated dose - MLC tracking
Timepoint [5] 0 0
Assessed at 2 years
Secondary outcome [6] 0 0
Treated dose - standard
Timepoint [6] 0 0
Assessed at 2 years
Secondary outcome [7] 0 0
4D Cone Beam CT (CBCT) image quality
Timepoint [7] 0 0
Assessed at 2 years
Secondary outcome [8] 0 0
Breathing variations with and without continuous positive air pressure (CPAP)
Timepoint [8] 0 0
At time of treatment

Eligibility
Key inclusion criteria
* Aged 18 or older
* Has provided written Informed Consent for participation in this trial and is willing to comply with the study
* Patients undergoing external beam radiotherapy at Northern Sydney Cancer Centre
* Histologically proven Stage I Non Small Cell Lung Cancer (NSCLC) oligometastatic lung metastases (3 or less). Histological diagnosis will be obtained if clinically indicated.
* MRI/4D-CT prior to insertion of Calypso beacons
* Patient must be able to have Varian Calypso beacons placed in the lung (if on anticoagulants, must be cleared by Local Medical Officer (LMO) or cardiologist).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Body habitus enabling Calypso tracking (as per Calypso Determining a Patient's Localisation Designation & Orientation before implantation)
* A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
* Tumour diameter = = 5cm
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous high-dose thoracic radiotherapy.
* Less than two Calypso beacons implanted in the lung.
* Calypso beacons are spaced by greater than 9cm or less than 1cm.
* Calypso beacons are less than 19cm from outer chest wall
* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators)
* Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment
* Women who are pregnant or lactating.
* Unwilling or unable to give informed consent
* Unwilling or unable to complete quality of life questionnaires

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2112 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Varian Medical Systems
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Eade, MD
Address 0 0
RNSH
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data is to be shared with USyd to fulfil the secondary endpoints of the trial
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT02514512