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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000781
Receipt No. R000000936
Scientific Title Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer
Date of disclosure of the study information 2007/08/01
Last modified on 2014/07/30

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Basic information
Public title Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer
Acronym CBDCA+GEM vs TS1+DTX phase II trial for completely resected lung cancer
Scientific Title Randomized phase II trial of adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX) for completely resected non-small cell lung cancer
Scientific Title:Acronym CBDCA+GEM vs TS1+DTX phase II trial for completely resected lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relapse free survival of completely resected non-small cell lung cancer with adjuvant chemotherapy (CBDCA+GEM vs TS1+DTX)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year relapse free survival
Key secondary outcomes toxicity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 adjuvant chemotherapy with CBDCA+GEM
Interventions/Control_2 adjuvant chemotherapy with TS1+DTX
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
76 years-old >
Gender Male and Female
Key inclusion criteria non-small cell lung cancer
lobectomy or more with ND2 lymphnode dissection
complete resection
pathological stage IB, II, IIIA
ECOG performance status 0, 1
Key exclusion criteria symptomatic interstitial pneumonia
multiple lung cancer or other-type cancer within 5 years
severe organ failure
past history of radiotherapy or chemotherapy
pregnant or expecting mother
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Tsushima
Organization Hirosaki University Hospital
Division name Department of Thoracic Surgery
Zip code
Address 53Honcho, Hirosaki, Aomori
TEL 0172-39-5074
Email tsusim@cc.hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiaki Endo
Organization Japanese Northern East Area Thoracic Surgery Study Group
Division name Central study center
Zip code
Address 4-1Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8526
Homepage URL
Email endo@idac.tohoku.ac.jp

Sponsor
Institute Japanese Northern East Area Thoracic Surgery Study Group
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 弘前大学病院(青森県)、青森県立中央病院(青森県)、岩手県立胆沢病院(岩手県)、東北大学病院(宮城県)、宮城がんセンター(宮城県)、山形大学病院(山形県)、福島医大病院(福島県)、太田西の内病院(福島県)、総合南東北病院(福島県)、金沢医大病院(石川県)、芳珠記念病院(石川県)、獨協医大病院(栃木県)

Other administrative information
Date of disclosure of the study information
2007 Year 08 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
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 No longer recruiting
Date of protocol fixation
2007 Year 06 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2011 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 11 Month 01 Day
Date trial data considered complete
2014 Year 11 Month 01 Day
Date analysis concluded
2014 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 30 Day
Last modified on
2014 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000936

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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