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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042218
Receipt No. R000048189
Scientific Title The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study)
Date of disclosure of the study information 2020/10/23
Last modified on 2021/07/13

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Basic information
Public title The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study)
Acronym AFTER NIVO ESO study
Scientific Title The efficacy and safety of taxane therapy after discontinuation of nivolumab therapy in Japanese patients with advanced or recurrent esophageal cancer:a retrospective observational study (AFTER NIVO ESO Study)
Scientific Title:Acronym AFTER NIVO ESO study
Region
Japan

Condition
Condition advanced or recurrent esophageal cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of taxanes administered as third-line therapy after discontinuation of nivolumab therapy with Japanese patients with advanced / recurrent esophageal cancer who received nivolumab in the ATTRACTION-3 (Clinical Trial Number: ONO-4538-24) study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate of taxanes administered as third-line therapy after nivolumab therapy
Key secondary outcomes - PFS of taxanes after nivolumab
- OS of taxanes after nivolumab
- Tumor response rate of target lesions from the start to the end of taxanes treatment
- TTF from the start to the end of taxane treatment
- Safety of taxanes
- PFS from the start of nivolumab treatment to taxane treatment (PFS2)
- OS from the start of nivolumab treatment (OS2)
- Time from discontinuation of nivolumab treatment to start of taxane treatment (TFS)
- Efficacy and safety of taxanes in each subgroup

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 Japanese patients with advanced/recurrent esophageal cancer who received nivolumab in ATTRACTION-3 and a taxane in the 3rd-line treatment (Paclitaxel or docetaxel)
(Patients who started receiving a taxane as a third-line treatment by November 12, 2018)
Key exclusion criteria Patients who withdrew consent before the analysis of this study
Target sample size 77

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Matsumoto
Organization Ono Pharmaceutical CO., LTD
Division name Oncology Medical , Medical Affairs
Zip code 541-8564
Address 8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL 06-6263-2992
Email hi.matsumoto@ono.co.jp

Public contact
Name of contact person
1st name Toshiaki
Middle name
Last name Kato
Organization EP-CRSU Co., Ltd
Division name Clinical Business Operation Headquarters, Clinical Research Management Center
Zip code 541-0043
Address King Osaka Bldg., 1-7 Toyotsucho, Suita-city, Osaka, Japan
TEL 06-7176-5731
Homepage URL
Email prj-after_niv@eps.co.jp

Sponsor
Institute Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
Institute
Department

Funding Source
Organization Ono Pharmaceutical CO.,LTD.
Bristol-Myers Squibb K.K.
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 Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address 8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel 06-6263-2992
Email n.nishiwaki@ono.co.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 10 Month 23 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 09 Day
Date of IRB
2020 Year 10 Month 16 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a non-interventional, medical record review of clinical data collected from Japanese patients using an electronic data collection (EDC) system.

Management information
Registered date
2020 Year 10 Month 23 Day
Last modified on
2021 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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