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

Neoplasms Clinical Trial

— LIGHTSABR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02514512
• Other study ID #: HREC/15/HAWKE/55
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Royal North Shore Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasms

Intervention

Device:
• MLC Tracking
Treat patient with Non FDA approved MLC Tracking

Locations

Country	Name	City	State
Australia	Royal North Shore Hospital	St Leonards	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Royal North Shore Hospital	University of Sydney, Varian Medical Systems

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	To demonstrate feasibility of MLC tracking for lung cancer	Percentage of fractions delivered without software or mechanical failure	Assessed at 2 years
Secondary	Audio Visual (AV) Biofeedback	Fraction of patients for whom AV biofeedback improves breathing regularity	Assessed at 2 years
Secondary	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
Secondary	Target volumes	Target volumes between the 4 Dimensional (4D) planning MLC tracking and Internal Target Volume (ITV) (standard) planning	Assessed at 2 years
Secondary	Lung dose	Difference in dose to healthy lung in treatment plans between 4D planning and ITV planning	Assessed at 2 years
Secondary	Treated dose - MLC tracking	Difference between the treated dose and planned dose for MLC tracking	Assessed at 2 years
Secondary	Treated dose - standard	Difference between the estimated treated dose and planned dose for ITV treatments	Assessed at 2 years
Secondary	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
Secondary	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