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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005901
Receipt No. R000006978
Scientific Title A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
Date of disclosure of the study information 2011/07/02
Last modified on 2014/01/02

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Basic information
Public title A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
Acronym A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
Scientific Title A phase III randomized trial of adjuvant therapy with irsogladine maleate for the patient with completely resected non-small cell lung cancer
Scientific Title:Acronym A phase III trial of adjuvant therapy with irsogladine maleate for the resected lung cancer patient
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 elucidate whether the prognoses of the resected lung cancer patients would improve or not after the administration of irsogladine maleate for 2 years
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes overall survival
Key secondary outcomes relapse-free survival

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 For the patient with rescted stage IA lung cancer, no adjuvant therapy is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil for 2 years is performed.
Interventions/Control_2 For the patient with rescted stage IA lung cancer, administration of irsogladine maleate for 2 years is performed. For the patient with resected stage IB - IIIA, administration of tegafur-uracil and irsogladine maleate for 2 years is performed.
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
25 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria non-small cell lung cancer
after complete resection
after lobectomy or peumonectomy
after hilar and mediastinal dissection
pathological stage IA - IIIA
no prior treatment
ECOG performance status 0-1
sufficient organ functions
written informed consent
Key exclusion criteria multiple cancer within 5 years
sever organ failure
past history of radiotherapy/chemotherapy
women with pregnancy or breast feeding
Target sample size 310

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kondo
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Department of Thoracic Surgery
Zip code
Address 4-1Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8521
Email sagawam@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motoyasu Sagawa
Organization Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
Division name Central study center
Zip code
Address 4-1Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-8526
Homepage URL
Email sagawam@kanazawa-med.ac.jp

Sponsor
Institute Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
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

Other administrative information
Date of disclosure of the study information
2011 Year 07 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.minervamedica.it/en/journals/minerva-chirurgica/
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 Completed
Date of protocol fixation
2000 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2001 Year 05 Month 01 Day
Last follow-up date
2013 Year 09 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
2011 Year 07 Month 01 Day
Last modified on
2014 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006978

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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