VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- University of Sydney
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).
Time Frame: 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.
Secondary Outcomes
- 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)