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

Not Applicable

Active, not recruiting

• Conditions: Neoplasms; Lung Neoplasms

• Registration Number: NCT02514512
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-12
• Study First Submitted QC: 2015-07-30
• Study First Posted: 2015-08-03
• Study Start: 2015-09
• Primary Completion: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate feasibility of MLC tracking for lung cancer	Assessed at 2 years	Percentage of fractions delivered without software or mechanical failure

Secondary Outcome Measures

Name	Time	Method
Lung dose	Assessed at 2 years	Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning
Treated dose - MLC tracking	Assessed at 2 years	Difference between the treated dose and planned dose for MLC tracking
Treated dose - standard	Assessed at 2 years	Difference between the estimated treated dose and planned dose for ITV treatments
Audio Visual (AV) Biofeedback	Assessed at 2 years	Fraction of patients for whom AV biofeedback improves breathing regularity
Coefficient of variation in breathing patterns	Assessed at 2 years	Breathing variations over imaging and treatment sessions with and without AV biofeedback using a statistical process for coefficient of variation
Target volumes	Assessed at 2 years	Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning
4D Cone Beam CT (CBCT) image quality	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.
Breathing variations with and without continuous positive air pressure (CPAP)	At time of treatment	To quantify the breathing variations over treatment sessions with and without application of continuous positive air pressure (CPAP)

Trial Locations

Locations (1)

Royal North Shore Hospital; 🇦🇺 St Leonards, New South Wales, Australia