About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Healthy lung sparing treatment plan
DeviceCT 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Interventional arm patients will have reduced treatment lung side-effects.
Toxicities will be collected at each patient visit.
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.
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.
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.
Sponsors and contacts
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University of Sydney
Lead sponsor
Liverpool Hospital
Collaborator
Royal North Shore Hospital
Collaborator
The Alfred
Collaborator
Peter MacCallum Cancer Centre, Australia
Collaborator
Fundacion GenesisCare
Collaborator