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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034595


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name