Clinical trial NCT02514512: Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation And Radiofrequency Tracking
Official title: Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neoplasms
Lung Neoplasms
Keywords: Lung Cancer
Stereotactic Ablative Radiotherapy (SABR)
MLC Tracking
Radiotherapy
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
Collaborators: name: University of Sydney
name: Varian Medical Systems
First posted: 2015-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To demonstrate feasibility of MLC tracking for lung cancer
timeFrame: Assessed at 2 years
Secondary outcomes:
measure: Audio Visual (AV) Biofeedback
timeFrame: Assessed at 2 years
measure: Coefficient of variation in breathing patterns
timeFrame: Assessed at 2 years
measure: Target volumes
timeFrame: Assessed at 2 years
measure: Lung dose
timeFrame: Assessed at 2 years
measure: Treated dose - MLC tracking
timeFrame: Assessed at 2 years
measure: Treated dose - standard
timeFrame: Assessed at 2 years
measure: 4D Cone Beam CT (CBCT) image quality
timeFrame: Assessed at 2 years
measure: Breathing variations with and without continuous positive air pressure (CPAP)
timeFrame: At time of treatment
Other outcomes:
measure: Patient Outcomes - Composite
timeFrame: 5 years
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: RNSH
name: Thomas Eade, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.