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Trial record 1 of 1 for:    NCT02514512
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Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking (LIGHTSABR)

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ClinicalTrials.gov Identifier: NCT02514512
Recruitment Status : Unknown
Verified September 2019 by Associate Professor Thomas Eade, Royal North Shore Hospital.
Recruitment status was:  Recruiting
First Posted : August 3, 2015
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
University of Sydney
Varian Medical Systems
Information provided by (Responsible Party):
Associate Professor Thomas Eade, Royal North Shore Hospital

Brief Summary:
A research study into a new technology for adjustment of the radiotherapy beam to account for movement of lung tumours as the patient breathes during radiotherapy.

Condition or disease Intervention/treatment Phase
Neoplasms Lung Neoplasms Device: MLC Tracking Phase 1

Detailed Description:
Twenty patients 18 years of age or more and undergoing Stereotactic Body Radiotherapy (SBRT) at Northern Sydney Cancer Centre for lung cancer will receive the new treatment. Participants will be physically able to undergo all aspects of treatment and intellectually able to provide written informed consent and complete questionnaires. Beacons will be implanted in the patients' lung to allow the Multi Leaf Collimator (MLC) tracking equipment to follow precisely the movement of the lung. The difference in ability to track tumour movement between MLC and the current standard method will be compared to identify changes in study outcomes. Audiovisual (AV) Biofeedback will also be used to regulate patients' breathing during radiotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
No Intervention: Standard SABR
Patients receive standard treatment
Experimental: MLC Tracking SABR
Patients are treated with MLC tracking
Device: MLC Tracking
Treat patient with Non FDA approved MLC Tracking




Primary Outcome Measures :
  1. Feasibility [ Time Frame: Assessed at 2 years ]
    Percentage of fractions delivered without software or mechanical failure


Secondary Outcome Measures :
  1. Audio Visual (AV) Biofeedback [ Time Frame: Assessed at 2 years ]
    Fraction of patients for whom AV biofeedback improves breathing regularity

  2. Coefficient of variation in breathing patterns [ Time Frame: Assessed at 2 years ]
    Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation

  3. Target volumes [ Time Frame: Assessed at 2 years ]
    Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning

  4. Lung dose [ Time Frame: Assessed at 2 years ]
    Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning

  5. Treated dose - MLC tracking [ Time Frame: Assessed at 2 years ]
    Difference between the treated dose and planned dose for MLC tracking

  6. Treated dose - standard [ Time Frame: Assessed at 2 years ]
    Difference between the estimated treated dose and planned dose for ITV treatments

  7. 4D Cone Beam CT (CBCT) image quality [ Time Frame: Assessed at 2 years ]
    Image quality and target position differences between the Calypso-based 4D CBCT image reconstruction and Revs Per Minute (RPM)-based 4D CBCT image reconstruction using Feldkamp filtered backprojection (FDK and iterative reconstruction algorithms.

  8. Breathing variations with and without continuous positive air pressure (CPAP) [ Time Frame: At time of treatment ]
    To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)


Other Outcome Measures:
  1. Patient Outcomes - Composite [ Time Frame: 5 years ]
    Participants will be followed for 5 years to determine patient outcome3s, including radiation therapy toxicity, local control (whether the tumour has spread) and survival.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514512


Contacts
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Contact: Clare Banks, MPH 61 2 9463 1345 clare.banks@health.nsw.gov.au
Contact: Carol Kwong, RN 61 2 9463 1339 Carolyn.Kwong@health.nsw.gov.au

Locations
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Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2112
Contact: Clare Banks, MPH    61 2 9463 1345    clare.banks@health.nsw.gov.au   
Contact: Carol Kwong, RN    61 2 9463 1339    Carolyn.Kwong@health.nsw.gov.au   
Sponsors and Collaborators
Royal North Shore Hospital
University of Sydney
Varian Medical Systems
Investigators
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Principal Investigator: Thomas Eade, MD RNSH
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Associate Professor Thomas Eade, Royal North Shore Hospital
ClinicalTrials.gov Identifier: NCT02514512    
Other Study ID Numbers: HREC/15/HAWKE/55
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data is to be shared with USyd to fulfil the secondary endpoints of the trial
Keywords provided by Associate Professor Thomas Eade, Royal North Shore Hospital:
Lung Cancer
Stereotactic Ablative Radiotherapy (SABR)
MLC Tracking
Radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases