UMIN-CTR Clinical Trial

Basic information
Public title	An observation study of perioperative nintedanib therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Acronym	Nintedanib therapy in patients with NSCLC with IPF
Scientific Title	An observation study of perioperative nintedanib therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Scientific Title:Acronym	Nintedanib therapy in patients with NSCLC with IPF
Region	Japan

Condition
Condition	non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Safety
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Postoperative exacerbation-free time of IPF 2-year survival rate

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) Clinical stage I-IIIA Patient who has operative indication
Key exclusion criteria	Past history of chest surgery Alternative prior treatment for IPF Past history of chemotherapy or radiation for chest Administration of oxygen therapy Infectious disease requiring treatment
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Hidetaka Middle name Last name Uramoto
Organization	Kanazawa Medical University
Division name	Thoracic Surgery
Zip code	920-0293
Address	1-1 daigaku, Uchinada, Ishikawa Japan
TEL	0762862211
Email	hidetaka@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Nozomu Middle name Last name Motono
Organization	Kanazawa Medical University
Division name	Thoracic Surgery
Zip code	920-0293
Address	1-1 daigaku, Uchinada, Ishikawa, Japan
TEL	0762862211
Homepage URL
Email	motono@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	Kanazawa Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	The Institutional Review Boards of Kanazawa Medical University
Address	1-1 daigaku, Uchinada, Ishikawa, Japan
Tel	0762188346
Email	tiken@kanazawa-med.ac.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	2020 Year 03 Month 01 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	1
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	Terminated
Date of protocol fixation	2020 Year 02 Month 04 Day
Date of IRB	2020 Year 05 Month 01 Day
Anticipated trial start date	2020 Year 05 Month 02 Day
Last follow-up date	2020 Year 08 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2020 Year 02 Month 19 Day
Last modified on	2020 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045087