UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027782 |
|---|---|
| Receipt number | 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 12:39:53 |
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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
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
hagiyam@med.teikyo-u.acjp
Sponsor or person
Institute
Teikyo University Chiba Medeical Ceater
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031817
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
