An interventional study of Functional Lung Avoidance Thoracic Radiotherapy and Standard Thoracic Radiotherapy in Small Cell Lung Cancer, Limited Stage and Stage III Non-small Cell Lung Cancer, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 64 is close to the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion criteria:
Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
Functional Lung Avoidance Thoracic Radiotherapy The avoidance thoracic radiotherapy treatment plan will be designed to optimize such that radiation dose to functional lung identified by four-dimensional (4D) CT ventilation imaging is as low as reasonably achievable
Radiation: Functional Lung Avoidance Thoracic Radiotherapy
Standard Thoracic Radiotherapy The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging
Radiation: Standard Thoracic Radiotherapy
* 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
The 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
Serum biomarkers in association with radiation pneumonitis
Tumor necrosis factor-alpha, Transforming growth factor-beta concentration measured by ELISA
Time frame: At baseline, 1, 2, 3, 4, 6 months post-radiotherapy
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital