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

Phase IIIRecruiting

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.

Study details:

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

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Aged 18 years or older.
  2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  3. Histologically proven non-small cell lung cancer.
  4. Stage 3 as determined using the IASLC (International Association for the Study of Lung Cancer) 8th edition lung cancer staging guidelines.
  5. 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.
  6. Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.
  7. Pulmonary function tests within 8 weeks of registration.
  8. Willingness to give written informed consent.
  9. Willingness to comply with the study procedures and visit requirements.
  10. Available for follow up for a minimum of 12 months and up to 3 years.

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.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start: 2025-09-26

Primary completion:

Study completion finish:

study type

Study type

OTHER

phase

Phase

    Phase III

trial

Study ID

NCT06127654

Intervention or treatment

DEVICE: Healthy lung sparing treatment plan

Conditions

  • Lung Cancer

  • Condition: Lung Cancer

  • DEVICE: Healthy lung sparing treatment plan

  • Liverpool, New South Wales, Australia

  • Sponsor: University of Sydney

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Liverpool Hospital

Select from list below to view details:

  • Liverpool Hospital

    Liverpool, New South Wales, Australia

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Who is running the clinical trial?

UoS

University of Sydney

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Intervention
  • Lung sparing treatment plan
Device: Healthy lung sparing treatment plan
    NO_INTERVENTION: Control
    • Standard treatment plan

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      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.3 months

      Secondary Outcome

      MeasureDescriptionTime Frame
      Interventional arm patients will have reduced treatment lung side-effects.Toxicities will be collected at each patient visit.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.2 years
      In the interventional arm, a higher proportion of patients will receive immunotherapyAdjuvant therapy will be described for all patients as part of routine follow up.2 years
      In the interventional arm, a higher proportion of patients will complete immunotherapyAdjuvant therapy will be described for all patients as part of routine follow up.2 years
      Cost effectiveness will be demonstrated as measured via a health economics assessmentTo be determined2 years
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

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

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