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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027782
Receipt No. R000031817
Scientific Title The first line therapy by Teikyo-NKT before chemotherapy to patients with advanced non-small cell lung cancer.
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/16

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Basic information
Public title The first line therapy by Teikyo-NKT before chemotherapy to patients with advanced non-small cell lung cancer.
Acronym The first line therapy by Teikyo-NKT before chemotherapy to patients with advanced non-small cell lung cancer.
Scientific Title The first line therapy by Teikyo-NKT before chemotherapy to patients with advanced non-small cell lung cancer.
Scientific Title:Acronym The first line therapy by Teikyo-NKT before chemotherapy to patients with advanced non-small cell lung cancer.
Region
Japan

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

Objectives
Narrative objectives1 Feasibility and safety of Teikyo-NKT before chemothaepy to advanced non-small cell lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Feasibility and safety of Teikyo-NKT before chemothaepy to advanced non-small cell lung cancer.
Key secondary outcomes Efficacy of Teikyo-NKT before chemothaepy to advanced non-small cell lung cancer.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Therapy by Teikyo-NKT before chemotherapy to advanced non-small cell lung cancer.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria non small cell lung cancer
stage 3B 4
EGFR gene mutation negative
ALK gene mutation negative

PS 0 1
Key exclusion criteria autoimmune disease

HBsAg + HCVAb + HTLV-1Ab + HIVAb +

brain meta, carcinomatous pleurisy, carcinomatous peritonitis, carcinomatous meningitis (uncntrollable)

serious lung disease (interstitial pneumonia etc)

medication of steroid or immunosuppressant

multicentric cancer

Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Wada
Organization Teikyo University Chiba Medeical Ceater
Division name orthopedics
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba 299-0111 Japan
TEL 0436-62-1211
Email mail.chiba@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Hagiya
Organization Teikyo University Chiba Medeical Ceater
Division name internal medicine (respirology)
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba 299-0111 Japan
TEL 0436-62-1211
Homepage URL
Email hagiyam@med.teikyo-u.acjp

Sponsor
Institute Teikyo University Chiba Medeical Ceater
Institute
Department

Funding Source
Organization Teikyo University
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 21 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 16 Day
Last modified on
2017 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031817

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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