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Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking (LIGHTSABR)

Primary Purpose

Neoplasms, Lung Neoplasms

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
MLC Tracking
Sponsored by
Royal North Shore Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Lung Cancer, Stereotactic Ablative Radiotherapy (SABR), MLC Tracking, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal North Shore Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard SABR

MLC Tracking SABR

Arm Description

Patients receive standard treatment

Patients are treated with MLC tracking

Outcomes

Primary Outcome Measures

To demonstrate feasibility of MLC tracking for lung cancer
Percentage of fractions delivered without software or mechanical failure

Secondary Outcome Measures

Audio Visual (AV) Biofeedback
Fraction of patients for whom AV biofeedback improves breathing regularity
Coefficient of variation in breathing patterns
Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation
Target volumes
Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning
Lung dose
Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning
Treated dose - MLC tracking
Difference between the treated dose and planned dose for MLC tracking
Treated dose - standard
Difference between the estimated treated dose and planned dose for ITV treatments
4D Cone Beam CT (CBCT) image quality
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.
Breathing variations with and without continuous positive air pressure (CPAP)
To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)

Full Information

First Posted
July 12, 2015
Last Updated
October 25, 2022
Sponsor
Royal North Shore Hospital
Collaborators
University of Sydney, Varian Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02514512
Brief Title
Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking
Acronym
LIGHTSABR
Official Title
Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal North Shore Hospital
Collaborators
University of Sydney, Varian Medical Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Lung Neoplasms
Keywords
Lung Cancer, Stereotactic Ablative Radiotherapy (SABR), MLC Tracking, Radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard SABR
Arm Type
No Intervention
Arm Description
Patients receive standard treatment
Arm Title
MLC Tracking SABR
Arm Type
Experimental
Arm Description
Patients are treated with MLC tracking
Intervention Type
Device
Intervention Name(s)
MLC Tracking
Intervention Description
Treat patient with Non FDA approved MLC Tracking
Primary Outcome Measure Information:
Title
To demonstrate feasibility of MLC tracking for lung cancer
Description
Percentage of fractions delivered without software or mechanical failure
Time Frame
Assessed at 2 years
Secondary Outcome Measure Information:
Title
Audio Visual (AV) Biofeedback
Description
Fraction of patients for whom AV biofeedback improves breathing regularity
Time Frame
Assessed at 2 years
Title
Coefficient of variation in breathing patterns
Description
Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation
Time Frame
Assessed at 2 years
Title
Target volumes
Description
Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning
Time Frame
Assessed at 2 years
Title
Lung dose
Description
Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning
Time Frame
Assessed at 2 years
Title
Treated dose - MLC tracking
Description
Difference between the treated dose and planned dose for MLC tracking
Time Frame
Assessed at 2 years
Title
Treated dose - standard
Description
Difference between the estimated treated dose and planned dose for ITV treatments
Time Frame
Assessed at 2 years
Title
4D Cone Beam CT (CBCT) image quality
Description
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.
Time Frame
Assessed at 2 years
Title
Breathing variations with and without continuous positive air pressure (CPAP)
Description
To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)
Time Frame
At time of treatment
Other Pre-specified Outcome Measures:
Title
Patient Outcomes - Composite
Description
Participants will be followed for 5 years to determine patient outcome3s, including radiation therapy toxicity, local control (whether the tumour has spread) and survival.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Eade, MD
Organizational Affiliation
RNSH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2112
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is to be shared with USyd to fulfil the secondary endpoints of the trial
Citations:
PubMed Identifier
33263318
Citation
Caillet V, Zwan B, Briggs A, Hardcastle N, Szymura K, Prodreka A, O'Brien R, Harris BE, Greer P, Haddad C, Jayamanne D, Eade T, Booth J, Keall P. Geometric uncertainty analysis of MLC tracking for lung SABR. Phys Med Biol. 2020 Dec 2;65(23):235040. doi: 10.1088/1361-6560/abb0c6.
Results Reference
derived
PubMed Identifier
33152399
Citation
Booth J, Caillet V, Briggs A, Hardcastle N, Angelis G, Jayamanne D, Shepherd M, Podreka A, Szymura K, Nguyen DT, Poulsen P, O'Brien R, Harris B, Haddad C, Eade T, Keall P. MLC tracking for lung SABR is feasible, efficient and delivers high-precision target dose and lower normal tissue dose. Radiother Oncol. 2021 Feb;155:131-137. doi: 10.1016/j.radonc.2020.10.036. Epub 2020 Nov 3.
Results Reference
derived

Learn more about this trial

Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking

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