UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040704 |
|---|---|
| Receipt number | R000044054 |
| Scientific Title | Observation Study of Patients With Non-Small Cell Lung Cancer and Carcinomatous Meningitis Treated With whole-brain radiation or/and immune checkpoint inhibitors. |
| Date of disclosure of the study information | 2020/06/09 |
| Last modified on | 2025/02/10 11:42:20 |
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Basic information
Public title
Observation Study of Patients With Non-Small Cell Lung Cancer and Carcinomatous Meningitis Treated With whole-brain radiation or/and immune checkpoint inhibitors.
Acronym
Observation Study of Patients With Non-Small Cell Lung Cancer and Carcinomatous Meningitis Treated With whole-brain radiation or/and immune checkpoint inhibitors.
Scientific Title
Observation Study of Patients With Non-Small Cell Lung Cancer and Carcinomatous Meningitis Treated With whole-brain radiation or/and immune checkpoint inhibitors.
Scientific Title:Acronym
NEJ049 study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of WBRT and/or immune checkpoint inhibitor in
patients with LM from NSCLC, we carried out the retrospective study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Safety
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically diagnosed with NSCLC
2) Confirmed by brain MRI or cytollogy as leptomeningeal carcinomatosis
Key exclusion criteria
1) LCNEC and Combined SCLC
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hisatoshi |
| Middle name | |
| Last name | Sugiura |
Organization
Tohoku University Hospital
Division name
Department of respiratory medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 9808574 JAPAN
TEL
0227178539
sugiura@rm.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Eisaku |
| Middle name | |
| Last name | Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of respiratory medicine
Zip code
9808574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 9808574 JAPAN
TEL
0227178539
Homepage URL
miyauchi@rm.med.tohoku.ac.jp
Sponsor or person
Institute
North East Japan Study Group (NEJSG)
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group (NEJSG)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University IRB
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi 9808574 JAPAN
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
| 2020 | Year | 06 | Month | 09 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044054
