Phase I Feasibility Study of Lung Cancer Radiotherapy Using Realtime Dynamic Multileaf Collimator (MLC) Adaptation and Radiofrequency Tracking
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To demonstrate feasibility of MLC tracking for lung cancer
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard SABR
Patients receive standard treatment
MLC Tracking SABR
Patients are treated with MLC tracking
干预措施: MLC Tracking (Device)
结局指标
主要结局
To demonstrate feasibility of MLC tracking for lung cancer
时间窗: Assessed at 2 years
Percentage of fractions delivered without software or mechanical failure
次要结局
- Audio Visual (AV) Biofeedback(Assessed at 2 years)
- Coefficient of variation in breathing patterns(Assessed at 2 years)
- Lung dose(Assessed at 2 years)
- Treated dose - MLC tracking(Assessed at 2 years)
- Treated dose - standard(Assessed at 2 years)
- Target volumes(Assessed at 2 years)
- 4D Cone Beam CT (CBCT) image quality(Assessed at 2 years)
- Breathing variations with and without continuous positive air pressure (CPAP)(At time of treatment)
研究者
Professor Thomas Eade
Associate Professor Thomas Eade
Royal North Shore Hospital