About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically verified lung cancer (small-cell and non-small cell lung cancer)
referred for radiotherapy with curative intent
radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
concurrent chemotherapy is accepted
Disqualifiers
concurrent immunotherapy
previous radiotherapy to the thorax
other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
Trial design
Parallel
Treatments tested in this trial
Single-photon-emission CT scan
Diagnostic testSPECT/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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Quality of life
Change in quality of life according to the European Organisation for Research and Treatment of Cancer quality of life questionnaires
Patient reported lung symptoms
Change in lung symptoms according to the European Organisation for Research and Treatment of Cancer questionnaire
Progression-free survival
time from randomization to disease progression at any site or death
Overall survival
time from randomization to death of any cause or last date known alive
Sponsors and contacts
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University of Aarhus
Lead sponsor
Aarhus University Hospital
Sponsor institution
Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia
Collaborator
Aarhus University Hospital
Collaborator
South Eastern Sydney Local Health District
Collaborator
The University of New South Wales
Collaborator
Northern NSW Local Health District, NSW Australia
Collaborator