VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).
研究概览
简要总结
This research project is testing a new treatment planning method for patients with lung cancer who will be treated with radiation therapy. This new method is called Computed Tomography (CT) ventilation imaging. It aims to help protect the healthiest parts of patient's lungs from being injured by the radiation therapy. The investigators will determine whether healthy lung sparing can improve the quality of life in these patients.
详细描述
The planning and delivery of Radiation Therapy (RT) is a balance between delivering a curative dose to the tumour while sparing healthy organs, such as the lungs, from collateral damage such as pneumonitis. To minimise radiation-induced lung injury, our team has invented and pioneered ventilation imaging based on Computed Tomography (CT). This Australian-invented medical device, now an international field of research, uses CT scans routinely acquired for planning RT to compute a CT ventilation map showing high functioning and low functioning lung regions. This image is used as the basis for directing radiation away from the healthy, high functioning regions towards the low functioning regions, thereby aiming to reduce toxicity and improve the patient's quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 years or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Histologically proven non-small cell lung cancer.
- •Stage 3 as determined using the IASLC (International Association for the Study of Lung Cancer) 8th edition lung cancer staging guidelines.
- •To be treated with curative intent external beam radiotherapy (60 Gy in 30 treatments or 55 Gy in 20 treatments) +/- concurrent chemotherapy and adjuvant PD1/PD-L1 inhibitors.
- •Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.
- •Pulmonary function tests within 8 weeks of registration.
- •Willingness to give written informed consent.
- •Willingness to comply with the study procedures and visit requirements.
- •Available for follow up for a minimum of 12 months and up to 3 years.
- •Post-inclusion criteria includes the results of a Quality of Life (QoL) assessment and treatment plan assessment, neither of which are known prior to consent. The post-inclusion criteria for the VITaL trial are:
- •Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI) score of ≥5, the clinically meaningful difference
- •The standard treatment plan shows that at least 16% of volume of the lungs (minus the Gross Tumour Volume (GTV)) will receive more than 20 Gy. This criterion is based on the difference in pneumonitis risk between patients receiving below (~8%) and above (~34%) this threshold.
- •The QoL assessment is unlikely to eliminate any patients but is included for patients where no clinically meaningful difference will be possible. The treatment plan assessment may exclude 20% of otherwise eligible patients.
排除标准
- •Serious medical comorbidities that may contraindicate curative radiotherapy.
- •Inability to attend full course of radiotherapy or follow-up visits.
- •A current or former diagnosis of interstitial lung disease.
- •Prior history of lung cancer within 5 years.
- •Prior thoracic radiotherapy at any time.
- •Prior surgery for this cancer within a year.
- •Prior chemotherapy for this cancer.
- •Pregnant or lactating women.
研究组 & 干预措施
Control
Standard treatment plan
Intervention
Lung sparing treatment plan
干预措施: Healthy lung sparing treatment plan (Device)
结局指标
主要结局
Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).
时间窗: 3 months
Patients in the interventional healthy lung sparing arm will maintain their 3-month quality of life (measured via the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire) more than patients receiving standard care by a clinically meaningful difference.
次要结局
- Interventional arm patients will have reduced treatment lung side-effects.(2 years)
- Interventional arm patients will have better lung function, as determined by the difference between pre and post treatment Forced Expiratory Volume (FEV1) scores, as healthy lung is spared.(2 years)
- In the interventional arm, a higher proportion of patients will complete immunotherapy(2 years)
- In the interventional arm, a higher proportion of patients will receive immunotherapy(2 years)
- Cost effectiveness will be demonstrated as measured via a health economics assessment(2 years)