UMIN-CTR Clinical Trial

Basic information
Public title	Long term follow-up protocol of phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer.(WJOG0105LFS)
Acronym	Follow up study of WJTOG0105
Scientific Title	Long term follow-up protocol of phase III study comparing second- and third-generation regimens with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer.(WJOG0105LFS)
Scientific Title:Acronym	Follow up study of WJTOG0105
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is that we investigate long term follow-up results of third-generation regimens with concurrent thoracic radiotherapy in unresectable stage III non-small cell lung cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
Key secondary outcomes	Prgression-free survival, Pattern of relapse, Post treatment after progression, Late toxicity.

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	All cases of registerd with WJTOG0105.
Key exclusion criteria	None
Target sample size	440

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Tsuboi
Organization	National Cancer Center Hospital East
Division name	Thoracic Surgery
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa City, Chiba Prefecture, Japan
TEL	04-7133-1111
Email	mtsuboi@east.ncc.go.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code	556-0016
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
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	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address	3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677
Tel	03-3823-2101
Email	yzenke@cick.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	2018 Year 01 Month 15 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	331
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	2018 Year 01 Month 13 Day
Date of IRB	2018 Year 01 Month 30 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 12 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective analysis of long-term follow-up survival with WJTOG0105.

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2021 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035016