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

Royal North Shore Hospital

Status: Active, not recruiting

Conditions: Lung Neoplasms; Neoplasms

Treatments: Device: MLC Tracking

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02514512

HREC/15/HAWKE/55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Standard SABR

No Intervention group

Description:

Patients receive standard treatment

MLC Tracking SABR

Experimental group

Description:

Patients are treated with MLC tracking

Treatment:

Device: MLC Tracking