Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy (VITaL)

VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Device: Healthy lung sparing treatment plan

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.

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shona Silvester; Phone Number: +61413681368; Email: shona.silvester@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Recruiting
      • SWSLHD - Liverpool, Campbelltown and Bankstown-Lidcombe Hospitals
      • Contact: Clinical Trial Coordinator; Phone Number: +61 2 8738 5180; Email: SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Aged 18 years or older.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
3. Histologically proven non-small cell lung cancer.
4. Stage 3 as determined using the IASLC (International Association for the Study of Lung Cancer) 8th edition lung cancer staging guidelines.
5. 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.
6. Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.
7. Pulmonary function tests within 8 weeks of registration.
8. Willingness to give written informed consent.
9. Willingness to comply with the study procedures and visit requirements.
10. 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:

1. Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI) score of ≥5, the clinically meaningful difference
2. 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.

Exclusion Criteria:

1. Serious medical comorbidities that may contraindicate curative radiotherapy.
2. Inability to attend full course of radiotherapy or follow-up visits.
3. A current or former diagnosis of interstitial lung disease.
4. Prior history of lung cancer within 5 years.
5. Prior thoracic radiotherapy at any time.
6. Prior surgery for this cancer within a year.
7. Prior chemotherapy for this cancer.
8. Pregnant or lactating women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Lung sparing treatment plan	Device: Healthy lung sparing treatment plan; CT Ventilation imaging will be used to create a healthy lung sparing treatment plan for patients who will receive radiation therapy treatment for their lung cancer.
No Intervention: Control; Standard treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interventional arm patients will have reduced treatment lung side-effects.	Toxicities will be collected at each patient visit.	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.	Lung function tests (FEV-1) will be acquired at routine time points within the trial, including pre and post treatment.	2 years
In the interventional arm, a higher proportion of patients will receive immunotherapy	Adjuvant therapy will be described for all patients as part of routine follow up.	2 years
In the interventional arm, a higher proportion of patients will complete immunotherapy	Adjuvant therapy will be described for all patients as part of routine follow up.	2 years
Cost effectiveness will be demonstrated as measured via a health economics assessment	To be determined	2 years

Collaborators and Investigators

• Sponsor: University of Sydney
• Collaborators: The Alfred; Peter MacCallum Cancer Centre, Australia; Royal North Shore Hospital; Fundacion GenesisCare; Liverpool Hospital
• Investigators: Principal Investigator: Paul Keall, PhD, University of Sydney

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Quality of Life; Pneumonitis; Curative treatment; Healthy lung sparing
• Additional Relevant MeSH Terms: Neoplasms by Site; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms; Lung Neoplasms; Pneumonia
• Other Study ID Numbers: IX-2022-CT-VITAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study findings have been published, un-identifiable (non-coded, completely de-identified) data will be shared with researchers or at an external data repository for further scientific research.
• IPD Sharing Time Frame: Data will be made available following the publication of the final results.
• IPD Sharing Access Criteria: Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University of Sydney.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No