UMIN-CTR Clinical Trial

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
Email	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
Email	yoshihito_ohhara@yahoo.co.jp

Sponsor
Institute	KKR Sapporo Medical Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034595