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

Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neoplasms; Lung Neoplasms
• Intervention / Treatment: Device: MLC Tracking

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2112
      • Royal North Shore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate feasibility of MLC tracking for lung cancer	Percentage of fractions delivered without software or mechanical failure	Assessed at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audio Visual (AV) Biofeedback	Fraction of patients for whom AV biofeedback improves breathing regularity	Assessed at 2 years
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	Assessed at 2 years
Target volumes	Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning	Assessed at 2 years
Lung dose	Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning	Assessed at 2 years
Treated dose - MLC tracking	Difference between the treated dose and planned dose for MLC tracking	Assessed at 2 years
Treated dose - standard	Difference between the estimated treated dose and planned dose for ITV treatments	Assessed at 2 years
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.	Assessed at 2 years
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)	At time of treatment

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royal North Shore Hospital
• Collaborators: University of Sydney; Varian Medical Systems
• Investigators: Principal Investigator: Thomas Eade, MD, RNSH

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 12, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimated): August 3, 2015

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lung Cancer; Radiotherapy; Stereotactic Ablative Radiotherapy (SABR); MLC Tracking
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HREC/15/HAWKE/55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data is to be shared with USyd to fulfil the secondary endpoints of the trial