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

NCT06127654 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: IX-2022-CT-VITAL
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Pneumonitis; Quality of Life; Curative treatment; Cancer; Healthy lung sparing

Outcome Measures

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.

  3 months

Secondary Outcomes (5)

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

  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.

  2 years

• In the interventional arm, a higher proportion of patients will receive immunotherapy

  2 years

• In the interventional arm, a higher proportion of patients will complete immunotherapy

  2 years

• Cost effectiveness will be demonstrated as measured via a health economics assessment

  2 years

Study Arms (2)

Intervention

EXPERIMENTAL

Lung sparing treatment plan

Device: Healthy lung sparing treatment plan

Control

NO INTERVENTION

Standard treatment plan

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.
• Pulmonary function tests within 8 weeks of registration.
• Willingness to give written informed consent.
• Willingness to comply with the study procedures and visit requirements.
• Available for follow up for a minimum of 12 months and up to 3 years.
• Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI) score of ≥5, the clinically meaningful difference
• The standard treatment plan shows that at least 16% of volume of the lungs (minus the Gross Tumour Volume (GTV)) will receive more than 20 Gy. This criterion is based on the difference in pneumonitis risk between patients receiving below (\~8%) and above (\~34%) this threshold.
• The QoL assessment is unlikely to eliminate any patients but is included for patients where no clinically meaningful difference will be possible. The treatment plan assessment may exclude 20% of otherwise eligible patients.

You may not qualify if:

• 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.
• Prior thoracic radiotherapy at any time.
• Prior surgery for this cancer within a year.
• Prior chemotherapy for this cancer.
• Pregnant or lactating women.

Sponsors & Collaborators

• University of Sydney: lead
• Liverpool Hospital: collaborator
• Royal North Shore Hospital: collaborator
• The Alfred: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• Fundacion GenesisCare: collaborator

Study Sites (1)

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

MeSH Terms

Conditions

Lung Neoplasms; Pneumonia; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections

Study Officials

• Paul Keall, PhD

  University of Sydney

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shona Silvester

CONTACT

+61413681368; shona.silvester@sydney.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 13, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will be made available following the publication of the final results.
• Access Criteria: Data will only be shared with repositories whose function has been reviewed and approved by an accredited Research Integrity/Ethics Committee/Board, under a Materials Transfer Agreement with the University of Sydney.

Locations

AU (1)