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

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Healthy lung sparing treatment plan

    Device

    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.

Treatment groups

165 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months

Secondary outcomes

1

Interventional arm patients will have reduced treatment lung side-effects.

Toxicities will be collected at each patient visit.

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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