Image-Guided Functional Lung Avoidance Thoracic Radiotherapy for Lung Cancer: A Single-Blind Randomized Trial

Not Applicable

• Conditions: Small Cell Lung Cancer, Limited Stage; Stage III Non-small Cell Lung Cancer

• 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

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-13
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-11
• Primary Completion: 2021-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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