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Peer-reviewedCC BYClinical and translational radiation oncology

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.

  • Shalini K Vino D1,2,3,4
  • Val Gebski5
  • Sashendra Senthi6,7
  • Cynleen Kai8
  • Dasantha Jayamanne9,10,11
  • David Palma12,13
  • Nicholas Hardcastle14,15
  • Hilary L Byrne10,16
  • Douglas A Hoover12,13
  • John Kipritidis9,16
  • Anthony Espinoza1
  • Benjamin Zwan17,18
14 more authors
  • Guneet Kaur10,16
  • Amit Sawant19
  • Bilal A Tahir20,21
  • Rebecca Mercieca-Bebber5
  • Karan K Shah5
  • Andrew Bowen22
  • Miriam Cavanagh23
  • Lee Hunt24
  • Surein Arulananda25,26
  • Helen Ball16
  • Nina Eikelis27
  • Alisha Moore28
  • Shona Silvester16
  • Paul Keall16
28 affiliations
  1. 1Cancer Therapy Centre, Liverpool Hospital, South Western Sydney Local Health District, NSW, Australia.
  2. 2South West Sydney Clinical Campuses, School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
  3. 3Sydney School of Public Medicine & Health, University of Sydney, Sydney, NSW, Australia.
  4. 4Collaboration for Cancer Outcomes Research and Evaluation (CCORE), Ingham Institute for Applied Medical Research, Liverpool, NSW, Australia.
  5. 5Sydney Clinical Trials Centre, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
  6. 6Alfred Health Radiation Oncology, Melbourne, VIC, Australia.
  7. 7Central Clinical School, Monash University, Melbourne, VIC, Australia.
  8. 8Austin Health, Melbourne, VIC, Australia.
  9. 9Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, NSW, Australia.
  10. 10Genesis Care, Sydney, NSW, Australia.
  11. 11Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
  12. 12Verspeeten Family Cancer Centre, London Health Sciences Centre, London, Ontario, Canada.
  13. 13Division of Radiation Oncology, Western University, London, Canada.
  14. 14Department of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.
  15. 15Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.
  16. 16Image X Institute, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.
  17. 17Central Coast Cancer Centre, Gosford Hospital, Gosford, NSW, Australia.
  18. 18School of Information and Physical Sciences, The University of Newcastle, Newcastle, NSW, Australia.
  19. 19Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, USA.
  20. 20POLARIS, Section of Medical Imaging and Technologies, Division of Clinical Medicine, School of Medicine and Population Health, University of Sheffield, Sheffield, United Kingdom.
  21. 21Insigneo Institute for in silico Medicine, University of Sheffield, Sheffield, United Kingdom.
  22. 22Thoracic Oncology Group of Australasia, Thornbury VIC, Australia.
  23. 23Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia.
  24. 24Cancer Voices NSW, Milsons Point, NSW, Australia.
  25. 25Department of Medical Oncology, Monash Health, Melbourne, VIC, Australia.
  26. 26School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.
  27. 274DMedical, Melbourne, VIC, Australia.
  28. 28Trans-Tasman Radiation Oncology Group, Waratah, NSW, Australia.
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Abstract

Background

Radiation therapy (RT) is indicated for 77% of patients with lung cancer. Over 20% of patients are affected by radiation-induced lung injury. Computed tomography ventilation imaging (CTVI) estimates high and low functioning lung regions. During RT planning, CTVI can guide preferential avoidance of higher ventilated regions by redirecting dose to less well ventilated regions, sparing healthy lung tissue. The double-masked randomized Trans-Tasman Radiation Oncology Group (TROG) 21.08 VITaL trial will investigate if sparing healthy lung can improve the quality of life (QoL) for patients with stage 3 non-small cell lung cancer (NSCLC) treated with RT.Methods

165 patients will be recruited to test the hypothesis that patients receiving healthy lung-sparing RT have better QoL than patients receiving standard RT. CTVI will be generated from exhale and inhale breath-hold CT scan pairs. A healthy lung-sparing plan and a standard treatment plan will be created for each patient and randomly assigned in a 1:1 ratio for the patient's treatment. QoL will be assessed with the Functional Assessment of Cancer Therapy-Lung questionnaire before and after treatment. Secondary hypotheses include that patients in the healthy lung-sparing arm will have fewer treatment side effects, better lung function, be more likely to receive and complete adjuvant immunotherapy, and healthy lung-sparing treatment will be cost-effective. Patient follow-up will continue for three years.Discussion

This prospective randomized trial will determine whether the incorporation of healthy lung-sparing RT based on CTVI improves QoL, reduces pulmonary toxicity, and increases eligibility to receive curative immunotherapy for patients with stage 3 NSCLC.Trial registration

ClinicalTrials.gov (NCT06127654).

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Cite

BibTeXRIS
BibTeX
@article{vino2026study,
  title = {{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.}},
  author = {Shalini K Vino D and Val Gebski and Sashendra Senthi and Cynleen Kai and Dasantha Jayamanne and David Palma and Nicholas Hardcastle and Hilary L Byrne and Douglas A Hoover and John Kipritidis and Anthony Espinoza and Benjamin Zwan and Guneet Kaur and Amit Sawant and Bilal A Tahir and Rebecca Mercieca-Bebber and Karan K Shah and Andrew Bowen and Miriam Cavanagh and Lee Hunt and Surein Arulananda and Helen Ball and Nina Eikelis and Alisha Moore and Shona Silvester and Paul Keall},
  journal = {Clinical and translational radiation oncology},
  year = {2026},
  month = oct,
  doi = {10.1016/j.ctro.2026.101312},
  url = {https://europepmc.org/article/MED/42910049},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - 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.
AU  - Shalini K Vino D
AU  - Val Gebski
AU  - Sashendra Senthi
AU  - Cynleen Kai
AU  - Dasantha Jayamanne
AU  - David Palma
AU  - Nicholas Hardcastle
AU  - Hilary L Byrne
AU  - Douglas A Hoover
AU  - John Kipritidis
AU  - Anthony Espinoza
AU  - Benjamin Zwan
AU  - Guneet Kaur
AU  - Amit Sawant
AU  - Bilal A Tahir
AU  - Rebecca Mercieca-Bebber
AU  - Karan K Shah
AU  - Andrew Bowen
AU  - Miriam Cavanagh
AU  - Lee Hunt
AU  - Surein Arulananda
AU  - Helen Ball
AU  - Nina Eikelis
AU  - Alisha Moore
AU  - Shona Silvester
AU  - Paul Keall
PY  - 2026
DA  - 2026/10/08
JO  - Clinical and translational radiation oncology
DO  - 10.1016/j.ctro.2026.101312
UR  - https://europepmc.org/article/MED/42910049
AB  - Background  Radiation therapy (RT) is indicated for 77% of patients with lung cancer. Over 20% of patients are affected by radiation-induced lung injury. Computed tomography ventilation imaging (CTVI) estimates high and low functioning lung regions. During RT planning, CTVI can guide preferential avoidance of higher ventilated regions by redirecting dose to less well ventilated regions, sparing healthy lung tissue. The double-masked randomized Trans-Tasman Radiation Oncology Group (TROG) 21.08 VITaL trial will investigate if sparing healthy lung can improve the quality of life (QoL) for patients with stage 3 non-small cell lung cancer (NSCLC) treated with RT.Methods  165 patients will be recruited to test the hypothesis that patients receiving healthy lung-sparing RT have better QoL than patients receiving standard RT. CTVI will be generated from exhale and inhale breath-hold CT scan pairs. A healthy lung-sparing plan and a standard treatment plan will be created for each patient and randomly assigned in a 1:1 ratio for the patient's treatment. QoL will be assessed with the Functional Assessment of Cancer Therapy-Lung questionnaire before and after treatment. Secondary hypotheses include that patients in the healthy lung-sparing arm will have fewer treatment side effects, better lung function, be more likely to receive and complete adjuvant immunotherapy, and healthy lung-sparing treatment will be cost-effective. Patient follow-up will continue for three years.Discussion  This prospective randomized trial will determine whether the incorporation of healthy lung-sparing RT based on CTVI improves QoL, reduces pulmonary toxicity, and increases eligibility to receive curative immunotherapy for patients with stage 3 NSCLC.Trial registration  ClinicalTrials.gov (NCT06127654).
SN  - 2405-6308
ER  -