UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041658
Receipt number R000045656
Scientific Title Nationwide survey of 10mg/kg biweekly bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer in Japan
Date of disclosure of the study information 2020/09/04
Last modified on 2021/11/04 17:22:33

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Basic information

Public title

Nationwide survey of 10mg/kg biweekly bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer in Japan

Acronym

Nationwide survey of 10mg/kg biweekly bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer in Japan

Scientific Title

Nationwide survey of 10mg/kg biweekly bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer in Japan

Scientific Title:Acronym

Nationwide survey of 10mg/kg biweekly bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer in Japan

Region

Japan


Condition

Condition

Platinum-resistant ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the real-world usage, efficacy and safety of 10 mg/kg biweekly bevacizumab for the treatment of platinum-resistant ovarian cancer in Japan

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the real-world usage, efficacy and safety of 10 mg/kg biweekly bevacizumab for the treatment of platinum-resistant ovarian cancer in Japan

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

Female

Key inclusion criteria

Patients who received bevacizumab in combination with chemotherapy for the treatment of platinum-resistant ovarian cancer between November 2013 and December 2018

Key exclusion criteria

None

Target sample size



Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Enomoto

Organization

Niigata University Graduate School of Medical And Dental Sciences

Division name

Department of obstetrics and gynecology

Zip code

951-8510

Address

1-757 Asahimachi-Dori, Chuo-ku Niigata city, Niigata 951-8510, Japan

TEL

025-227-2320

Email

enomoto@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Sekine

Organization

Niigata University Graduate School of Medical And Dental Sciences

Division name

Department of obstetrics and gynecology

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku Niigata city, Niigata 951-8510, Japan

TEL

025-227-2320

Homepage URL


Email

masa@med.niigata-u.ac.jp


Sponsor or person

Institute

Japan Society of Gynecologic Oncology

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical Co., Ltd.

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

Institutional Review Board Niigata University Medical & Dental Hospital

Address

754 Asahimachi-dori 1-bancho,Chuo-ku,Niigata-shi,Niigata,Japan

Tel

025-227-2436/2412

Email

joho@med.niigata-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



Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 04 Day


Related information

URL releasing protocol

Not posted

Publication of results

Unpublished


Result

URL related to results and publications

https://jsgo.or.jp/62/common/saitakukekka_0511.pdf, https://pubmed.ncbi.nlm.nih.gov/34308512/

Number of participants that the trial has enrolled

1633

Results

This survey revealed the real-world usage of 10 mg/kg biweekly bevacizumab for the treatment of platinum-resistant ovarian cancer in Japan.

Results date posted

2020 Year 09 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Refer to the published content

Participant flow

Refer to the published content

Adverse events

Refer to the published content

Outcome measures

Refer to the published content

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 08 Month 31 Day

Date of IRB

2018 Year 08 Month 31 Day

Anticipated trial start date

2018 Year 10 Month 10 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

Usage survey


Management information

Registered date

2020 Year 09 Month 02 Day

Last modified on

2021 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045656


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name