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Trial Title:
Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy
NCT ID:
NCT06127654
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Pneumonitis
Quality of Life
Curative treatment
Cancer
Healthy lung sparing
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Healthy lung sparing treatment plan
Description:
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.
Arm group label:
Intervention
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.
Criteria for eligibility:
Criteria:
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.
Post-inclusion criteria includes the results of a Quality of Life (QoL) assessment and
treatment plan assessment, neither of which are known prior to consent. The
post-inclusion criteria for the VITaL trial are:
1. Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI)
score of ≥5, the clinically meaningful difference
2. 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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 2024
Completion date:
December 2028
Lead sponsor:
Agency:
University of Sydney
Agency class:
Other
Collaborator:
Agency:
Liverpool Hospital
Agency class:
Other
Collaborator:
Agency:
Royal North Shore Hospital
Agency class:
Other
Collaborator:
Agency:
The Alfred
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Collaborator:
Agency:
Fundacion GenesisCare
Agency class:
Other
Source:
University of Sydney
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127654
