UMIN-CTR Clinical Trial

Basic information
Public title	Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Acronym	Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Scientific Title	Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Scientific Title:Acronym	Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the ratio of patients with interstitial lung disease who have received RT for lung cancer, the incidence of acute exacerbation in such patients, and the risk factors for acute exacerbation.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The ratio of acute exacerbation
Key secondary outcomes	The ratio of acute exacerbation related death The ratio of interstitial lung disease on radiation therapy for lung cancer

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosed as malignant tumor of lung. Diagnosed as interstitial lung disease. Case of radiotherapy.
Key exclusion criteria	Patients who have refused to use data.
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Yasushi Middle name Last name Nagata
Organization	Hiroshima University
Division name	Radiation Oncology Department
Zip code	734-8551
Address	Kasumi 4-9-1, Minami-ku Hiroshima, Japan
TEL	082-257-1545
Email	nagat@hiroshima-u.ac.jp

Public contact
1st name of contact person	1st name Yasuhito Middle name Last name Hagiwara
Organization	Yamagata University Faculty of Medicine
Division name	Department of Radiation Oncology
Zip code	990-9585
Address	Iidanishi 2-2-2, Yamagata, Japan
TEL	023-628-5386
Homepage URL
Email	hagiwara.yasuhito@gmail.com

Sponsor
Institute	Lung and Mediastinal Tumor Committee of Japanese Radiation Oncology Study Group (JROSG)
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kanagawa Cancer Center IRB
Address	Nakao 2-3-2, Asahi-ku, Yokohama, Japan
Tel	045-520-2222
Email	chiken-jimu4@kcch.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	67
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 31 Day
Date of IRB	2016 Year 09 Month 08 Day
Anticipated trial start date	2016 Year 09 Month 08 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 05 Month 24 Day
Last modified on	2019 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041976