UMIN-CTR Clinical Trial

Basic information
Public title	randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Acronym	randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Scientific Title	randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Scientific Title:Acronym	randomized study of Gemicitabine alone or UFT adjuvant chemotherapy for stage IB-IIIA non small cell lung cancer after complete resection
Region	Japan

Condition
Condition	stage IB-IIIA non small cell lung cancer after complete resection
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	experimental arm: gemicitabine 1000mg/m2, day1 and day 8, every 3 week, 6 cycle
Interventions/Control_2	standard arm: UFT 250mg/m2, daily for 1 year
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1.completely resected non small cell lung cancer 2.no prior anti cancer treatment for thoracic malignancy exept for this operation 3.pathological stage IB, II, and stage IIIA with only one station of n2 disease 4.PS 0-1 5.age 20-75 6.adequate oragan function for chemotherapy 7.written informed consent
Key exclusion criteria	1.small cell lung cancer or low grade malignancy of lung cancer 2.incomplete resection 3.apparant interstitial pneumonitis at chest rentogenogram 4.inadequate conditon for chemotherapy
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hirohito Tada, MD.
Organization	Osaka City General Hospital
Division name	Division of Thoracic Surgery
Zip code
Address	Miyakojima Hondhori 2-13-22
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Shinichiro Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code
Address
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
Address
Tel
Email

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	2005 Year 09 Month 06 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Main results already published
Date of protocol fixation	2001 Year 04 Month 28 Day
Date of IRB
Anticipated trial start date	2001 Year 06 Month 01 Day
Last follow-up date	2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 06 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000172

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.