MLC Tracking: Treat patient with Non FDA approved MLC Tracking
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)
To demonstrate feasibility of MLC tracking for lung cancer — Assessed at 2 years Percentage of fractions delivered without software or mechanical failure
Trial sites (1)
Facility
City
Region
Status
Royal North Shore Hospital
St Leonards
New South Wales
More Royal North Shore Hospital trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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