Thoracic radiotherapy (TRT) is a standard curative treatment for locally advanced, unresectable non-small cell lung cancer (NSCLC) and limited stage small cell lung cancer (SCLC). TRT has been recognized to cause moderate to severe lung injury in a substantial portion of patients. Conventional standard curative TRT planning techniques minimize the radiation dose to the anatomical lungs, without adaption of regional pulmonary function variations. The principal investigator hypothesized that preferential avoidance of functional lung during curative TRT may decrease the risk of pulmonary toxicity. Functional lung regions are identified using four- dimensional computed tomography for ventilation imaging. This randomized, single-blind trial will comprehensively assess the impact of functional lung avoidance on pulmonary toxicity, quality of life, and clinical outcome in patients receiving curative TRT for locally advanced NSCLC and SCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
* Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed) * Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed) * Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions
* Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed) * Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed) * Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions
National Taiwan University Hospital
Taipei, Taiwan
RECRUITINGThe pulmonary quality of life at 3 months post-radiotherapy
Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
Time frame: Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months
Changes of pulmonary function test post-radiotherapy
Screening spirometry, diffusion capacity of lung for carbon monoxide
Time frame: At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy)
Functional Assessment of Cancer Therapy-Lung
Time frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by EORTC Core)
EORTC Quality of Life-Core 30 questionnaire module
Time frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer)
EORTC Quality of Life questionnaire -Lung cancer 13
Time frame: At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy
Acute toxicity
Common Toxicity Criteria for Adverse Events version 4
Time frame: From date of radiotherapy until 90 days after radiotherapy starts
Late toxicity
Common Toxicity Criteria for Adverse Events version 4
Time frame: 90 days after radiotherapy starts until the date of death from any cause, up to 60 months
Progression free survival
Number of participant without disease progression
Time frame: From date of enrollment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Number of participant alive
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
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