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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
195
SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals
Sydney, New South Wales, Australia
NOT_YET_RECRUITINGDepartment of Oncology, Aarhus University Hospital
Aarhus, Denmark
RECRUITINGRadiation-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.
Time frame: Measured serially from 1 to 12 months after treatment completion
Quality of life
Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires
Time frame: 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
Time frame: Measured serially from 1 to 12 months after treatment completion
Progression-free survival
time from randomization to disease progression at any site or death
Time frame: at 12 months
Overall survival
time from randomization to death of any cause or last date known alive
Time frame: at 12 months
Loco-regional control rate
freedom from local disease progression
Time frame: at 12 months
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