Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial
- Conditions
- Small Cell Lung Cancer, Limited StageStage III Non-small Cell Lung Cancer
- Interventions
- Radiation: Functional Lung Avoidance Thoracic RadiotherapyRadiation: Standard Thoracic Radiotherapy
- Registration Number
- NCT03077854
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Functional Lung Avoidance-TRT Functional Lung Avoidance Thoracic Radiotherapy 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 Standard-TRT Standard Thoracic Radiotherapy Standard Thoracic Radiotherapy The standard thoracic radiotherapy treatment plan will be designed without reference to the functional lung 4D CT ventilation imaging
- Primary Outcome Measures
Name Time Method The pulmonary quality of life at 3 months post-radiotherapy Change from Baseline Functional Assessment of Cancer Therapy-Lung Cancer Subscale at 3 months Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS)
- Secondary Outcome Measures
Name Time Method Overall survival From date of enrollment until the date of death from any cause, assessed up to 60 months Number of participant alive
Patient reported outcome (Quality of Life questionnaire by EORTC Core) At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy EORTC Quality of Life-Core 30 questionnaire module
Acute toxicity From date of radiotherapy until 90 days after radiotherapy starts Common Toxicity Criteria for Adverse Events version 4
Late toxicity 90 days after radiotherapy starts until the date of death from any cause, up to 60 months Common Toxicity Criteria for Adverse Events version 4
Patient reported outcome (Quality of Life questionnaire by EORTC Lung cancer) At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy EORTC Quality of Life questionnaire -Lung cancer 13
Changes of pulmonary function test post-radiotherapy At baseline, 3, 6, 12 months, and annually until year 5 post-radiotherapy Screening spirometry, diffusion capacity of lung for carbon monoxide
Patient reported outcome (Quality of Life questionnaire by Functional Assessment of Cancer Therapy) At baseline, 1, 2, 3, 4, 6, 9 12 months post-radiotherapy Functional Assessment of Cancer Therapy-Lung
Progression free survival 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 Number of participant without disease progression
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan