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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoplasms Lung Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard SABR

Patients receive standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

MLC Tracking SABR

Patients are treated with MLC tracking

Group Type EXPERIMENTAL

MLC Tracking

Intervention Type DEVICE

Treat patient with Non FDA approved MLC Tracking

Interventions

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MLC Tracking

Treat patient with Non FDA approved MLC Tracking

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No