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Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.
Study details:
In this project, a novel method of safe radiotherapy delivery shall be tested for patients with lung cancer in a clinical setting. Functional avoidance radiotherapy is a new method that protect highly functional lung tissue from radiation, while delivering high dose radiotherapy to the lung tumour. Radiotherapy is usually based on a CT scan that does not account for functional variations in the lungs.
Therefore, I hypothesize that using functional distribution in the lungs and avoiding irradiation of highly functional lung will improve treatment outcome for individual patients with lung cancer. The objective of my project is to determine if functional image guided radiotherapy (functional avoidance radiotherapy) improves toxicity outcomes for patients with lung cancer undergoing curative chemo-radiotherapy in a prospective clinical trial. To reach this objective, the impact of functional avoidance radiotherapy on pulmonary toxicity measured by the incidence and severity of radiation-induced lung disease shall be assessed.
Additionally, loco-regional control, time to progression, overall survival, quality of life and radiation-induced molecular response in patients treated with functional avoidance radiotherapy shall be assessed and compared to patients receiving standard treatment.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-12-01
Primary completion: 2023-12-01
Study completion finish: 2024-12-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT04676828
Intervention or treatment
DIAGNOSTIC_TEST: Single-photon-emission CT scan
Conditions
- • Lung Cancer
- • Radiation-Induced Disorder
- • Radiation Pneumonitis
- • Pulmonary Disease
- • Lung Function Decreased
Find a site
Closest Location:
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Research sites nearby
Select from list below to view details:
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney, New South Wales, Australia
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/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: SPECT functional avoidance treatment
| DIAGNOSTIC_TEST: Single-photon-emission CT scan
|
NO_INTERVENTION: Standard treatment
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Radiation-induced lung toxicity | crude rate of symptomatic radiation-induced lung toxicity of grade 2 and higher. According to the Common Toxicity Criteria for Adverse Events version 5.0 for radiation pneumonitis, dyspnea, cough, or any other radiation-induced respiratory, thoracic and mediastinal disorder. | Measured serially from 1 to 12 months after treatment completion |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Quality of life | Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires | Measured serially from 1 to 12 months after treatment completion |
Patient reported lung symptoms | Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire | Measured serially from 1 to 12 months after treatment completion |
Progression-free survival | time from randomization to disease progression at any site or death | at 12 months |
Overall survival | time from randomization to death of any cause or last date known alive | at 12 months |
Loco-regional control rate | freedom from local disease progression | at 12 months |
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