UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020194
Receipt number R000023322
Scientific Title An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism
Date of disclosure of the study information 2016/01/31
Last modified on 2022/06/19 09:11:47

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Basic information

Public title

An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism

Acronym

An observational study for incidence of thromboembolism in lung cancer patients

Scientific Title

An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism

Scientific Title:Acronym

An observational study for incidence of thromboembolism in lung cancer patients

Region

Japan


Condition

Condition

Non-small cell lung cancer, small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the frequency of venous thromboembolism in lung cancer patient.
To evaluate the efficacy and safety of edoxaban in lung cancer patient with VTE.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Frequency of symptomatic and asymptomatic VTE

Key secondary outcomes



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

edoxaban 60 or 30mg/day for 6 months

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Pathologically or cytologically diagnosed non-small-cell or small cell lung cancer.
ECOG PS 0-3
Age over 20 years old.
Small cell lung cancer of ED-stage
Non-small-cell lung cancer of stage IIIB or IV
Reccurence of operation or concurrent chemoradiotherapy
Best supportive care patient
2 months or longer expected survival.
Written informed consent.

Key exclusion criteria

History of allergic reaction for edoxavan
Severe renal dysfunction (Ccr under 30 mL/min)
Severe liver disease
Interstitial pneumonia
Plannning for concurrent chemoradiotherapy
Started medication or treatment for VTE
Active bleeding
Severe hypertention
A pregnant woman, a woman in breast-feeding
Taking aspirin or two kind os antiplatelet drug
Acute infectious endocarditis
An inappropriate case judged by doctor in charge


Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Isobe

Organization

Shimane University Faculty of Medicine

Division name

Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

0853-20-2580

Email

isobeti@med.shimane-u.ac.jp


Public contact

Name of contact person

1st name Yukari
Middle name
Last name Tsubata

Organization

Shimane University Faculty of Medicine

Division name

Department of Internal Medicine Division of Medical Oncology & Respiratory Medicine

Zip code

693-8501

Address

89-1 Enya-cho, Izumo, Shimane

TEL

0853-20-2580

Homepage URL


Email

ytsubata@med.shimane-u.ac.jp


Sponsor or person

Institute

Shimane University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Daiichi Sankyo

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Research Ethics Committee, Shimane University Faculty of Medicine

Address

Enya-cho 89-1, Izumo, Shimane

Tel

0853202580

Email

kenkyu@med.shimane-u.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

島根大学医学部附属病院、県立広島病院、広島赤十字・原爆病院、呉医療センター・中国がんセンター、高知大学医学部附属病院、広島大学病院、広島市立安佐市民病院、国立病院機構高知病院、国立病院機構三重医療センター、市立三次病院


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

1025

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

2016 Year 02 Month 29 Day

Date of IRB

2016 Year 01 Month 13 Day

Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date

2021 Year 08 Month 13 Day

Date of closure to data entry

2021 Year 09 Month 30 Day

Date trial data considered complete

2021 Year 12 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 12 Month 14 Day

Last modified on

2022 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023322


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name