UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030313 |
|---|---|
| Receipt number | R000034595 |
| Scientific Title | Prognostic factors of non-small cell lung cancer patients with brain metastasis |
| Date of disclosure of the study information | 2017/12/08 |
| Last modified on | 2020/02/25 15:56:33 |
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Basic information
Public title
Prognostic factors of non-small cell lung cancer patients with brain metastasis
Acronym
Prognostic factors of non-small cell lung cancer patients with brain metastasis
Scientific Title
Prognostic factors of non-small cell lung cancer patients with brain metastasis
Scientific Title:Acronym
Prognostic factors of non-small cell lung cancer patients with brain metastasis
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the benefits of treatment for brain metastases in non-small cell cancer patients and to investigate the prognostic factors in those patients
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify the prognosis in non-small cell lung cancer patients with brain metastasis and investigate the prognostic factors in those patients
Key secondary outcomes
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
The patients with histologically confirme non-small cell lung cancer with brain metastasis at the point of diagnosis or recurrence in Hokkaido Lung Cancer Clinical Study Group (HOT) and cooperation hospitals from January 2008 through December 2014.
Key exclusion criteria
1) Histologically undiagnosed disease
2) Unable to get the clincal information from medical records
3) The cases of recurrence in brain metastasis after chemoradiotherapy
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Kojima |
Organization
KKR Sapporo Medical Center
Division name
Department of Medical Oncology
Zip code
062-0831
Address
1-jou 6-chome, Hiragishi, Toyohira-ku, Sapporo
TEL
011-822-1811
kotetsu@kkr-smc.com
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Ohhara |
Organization
Hokkaido University Hospital
Division name
Department of Medical Oncology
Zip code
060-8638
Address
West 5, North 14, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
yoshihito_ohhara@yahoo.co.jp
Sponsor or person
Institute
KKR Sapporo Medical Center
Institute
Department
Personal name
Funding Source
Organization
KKR Sapporo Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KKR Sapporo Medical Center
Address
1-jou 6-chome, Hiragishi, Toyohira-ku, Sapporo
Tel
011-822-1811
kotetsu@kkr-smc.com
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 | 12 | Month | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Age
2.Sex
3.date of diagnosis
4.ECOG performance status
5.smoking history
6.Clinical staging
7.metastatic sites
8.histological type
9.EGFR gene mutation
10.ALK fusion gene
11.date of diagnosis of brain metastasis
12.diagnostic devices of brain metastasis (CT/MRI)
13.location of brain metastasis
14.number of brain metastasis
15.longest diameter of brain metastasis
16.sum of diameters of brain metastases
17.symptons related with brain metastasis
18.brain edema
19.Meninges dissemination
20.Local treatmetent for brain metastases
21.Whole brain irradiation
22.local radiation therapy for brain metastases
23.surgery for brain metastases
24.dementia
25.systemic chemotherapy
26.total number of regimens
27.chemotherapy regimens
28.VEGF inhibitor
29.EGFR-TKI
30.ALK inhibitor
31.Immuno checkpoint inhibitor
32.clinical outcome, date of death, last follow-up date
Management information
Registered date
| 2017 | Year | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034595
