Lung CancerPhase 3VITaLNCT06127654
Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
A Phase 3 study testing Healthy lung sparing treatment plan in people with Lung Cancer, run by University of Sydney at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Healthy lung sparing treatment plan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
SWSLHD - Liverpool, Campbelltown and Bankstown-Lidcombe Hospitals
Liverpool, New South Wales, 2170
Clinical Trial Coordinator, +61 2 8738 5180, SWSLHD-RadOncClinicalTrials@health.nsw.gov.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Healthy lung sparing treatment plan
- Keywords
- Pneumonitis, Quality of Life, Curative treatment, Cancer, Healthy lung sparing
- Medical subject headings
- Lung Neoplasms, Pneumonia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy lung sparing treatment planDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Lung sparing treatment plan Receives: Device: Healthy lung sparing treatment plan |
| Control | No intervention | Standard treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
Interventional arm patients will have reduced treatment lung side-effects.
Toxicities will be collected at each patient visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Cost effectiveness will be demonstrated as measured via a health economics assessment
To be determined
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Hospital, Royal North Shore Hospital, The Alfred, Peter MacCallum Cancer Centre, Australia, Fundacion GenesisCare
- Responsible party
- Sponsor
- Investigators
- Paul Keall, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127654
- Sponsor's protocol ID
- IX-2022-CT-VITAL
- Acronym
- VITaL
- Status last verified
- May 2026
- First submitted
- 30 Oct 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Vino D SK, Gebski V, Senthi S, Kai C, Jayamanne D, Palma D, Hardcastle N, Byrne HL, Hoover DA, Kipritidis J, Espinoza A, Zwan B, Kaur G, Sawant A, Tahir BA, Mercieca-Bebber R, Shah KK, Bowen A, Cavanagh M, Hunt L, Arulananda S, Ball H, Eikelis N, Moore A, Silvester S, Keall P. Study protocol for the TROG 21.08 VITaL trial: a randomized controlled trial investigating ventilation imaging to improve the quality of life for patients with lung cancer treated with radiation therapy. Clin Transl Radiat Oncol. 2026 Oct 8;62:101312. doi: 10.1016/j.ctro.2026.101312. eCollection 2027 Jan.
PubMed 42910049
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT06127654
- Acronym / sponsor ID
- VITaL / IX-2022-CT-VITAL
- Conditions
- Lung Cancer
- Keywords
- Pneumonitis, Quality of Life, Curative treatment, Cancer, Healthy lung sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- Liverpool Hospital, Royal North Shore Hospital, The Alfred, Peter MacCallum Cancer Centre, Australia, Fundacion GenesisCare
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Healthy lung sparing treatment planLung sparing treatment plan |
| Control | No intervention | –Standard treatment plan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy lung sparing treatment planCT 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. | Device | Intervention |
Primary outcome
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.
5 secondary outcomes
Interventional arm patients will have reduced treatment lung side-effects.
Time frame: 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.
Time frame: 2 years
In the interventional arm, a higher proportion of patients will receive immunotherapy
Time frame: 2 years
In the interventional arm, a higher proportion of patients will complete immunotherapy
Time frame: 2 years
Cost effectiveness will be demonstrated as measured via a health economics assessment
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 42910049Vino D SK, Gebski V, Senthi S, Kai C, Jayamanne D, Palma D, Hardcastle N, Byrne HL, Hoover DA, Kipritidis J, Espinoza A, Zwan B, Kaur G, Sawant A, Tahir BA, Mercieca-Bebber R, Shah KK, Bowen A, Cavanagh M, Hunt L, Arulananda S, Ball H, Eikelis N, Moore A, Silvester S, Keall P. Study protocol for the TROG 21.08 VITaL trial: a randomized controlled trial investigating ventilation imaging to improve the quality of life for patients with lung cancer treated with radiation therapy. Clin Transl Radiat Oncol. 2026 Oct 8;62:101312. doi: 10.1016/j.ctro.2026.101312. eCollection 2027 Jan.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Keall, PhD principal investigator
University of Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Healthy lung sparing treatment plan in people with Lung Cancer, run by University of Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shona Silvester (+61413681368, shona.silvester@sydney.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm). (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06127654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.