UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041658
Receipt No. 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 2020/09/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Institute Japan Society of Gynecologic Oncology
Institute
Department

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
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
2020 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.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


Contact us.