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

Phase 3
Not yet recruiting
Conditions
Lung Cancer
Interventions
Device: Healthy lung sparing treatment plan
Registration Number
NCT06127654
Lead Sponsor
University of Sydney
Brief 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. 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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
165
Inclusion Criteria

Not provided

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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
InterventionHealthy lung sparing treatment planLung sparing treatment plan
Primary Outcome Measures
NameTimeMethod
Patients receiving healthy lung sparing treatment (interventional arm) have better quality of life than patients receiving standard treatment (control arm).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.

Secondary Outcome Measures
NameTimeMethod
In the interventional arm, a higher proportion of patients will receive immunotherapy2 years

Adjuvant therapy will be described for all patients as part of routine follow up.

Cost effectiveness will be demonstrated as measured via a health economics assessment2 years

To be determined

Interventional arm patients will have reduced treatment lung side-effects.2 years

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.2 years

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 complete immunotherapy2 years

Adjuvant therapy will be described for all patients as part of routine follow up.

Trial Locations

Locations (1)

Liverpool Hospital

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Liverpool, New South Wales, Australia

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