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

Sponsor

Royal North Shore Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02514512

Collaborator

University of Sydney (Other), Varian Medical Systems (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Feasibility [Assessed at 2 years]
Percentage of fractions delivered without software or mechanical failure

Secondary Outcome Measures

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
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
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)

Other Outcome Measures

Patient Outcomes - Composite [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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