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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032805
Receipt No. R000037420
Scientific Title Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.
Date of disclosure of the study information 2018/06/20
Last modified on 2018/05/31

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Basic information
Public title Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.
Acronym Randomized study as second-line chemotherapy in mUC patients.
Scientific Title Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.
Scientific Title:Acronym Randomized study as second-line chemotherapy in mUC patients.
Region
Japan

Condition
Condition metastatic urothelial carcinoma patients after treated first-line cisplatin based chemotherapy
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy as second-line treatment compared chemotherapy to immunotherapy using pembrolizumab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes progression free survival
Key secondary outcomes adverse events, overall survival, response to treatment, QOL after 2 cycles of treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gemcitabine and docetaxel combination chemotherapy
Interventions/Control_2 immunotherapy using pembrolizumab
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
80 years-old >=
Gender Male and Female
Key inclusion criteria The following World Health Organization criteria were met by all the enrolled patientsan adequate bone marrow reserve, reasonable hepatic function, and an estimated life expectancy of over 12 weeks. Ineligible patients included those with non-malignant systemic disease, such as active infection that precluded them from receiving therapy, or those with any clinically significant cardiac arrhythmia, and/or congestive heart failure. All patients provided written informed consent prior to this clinical trial. The institutional chemotherapy review boards (ethical committees) of Nagoya City University Hospital and Nagoya City University
Key exclusion criteria 1. allergy of gemcitabine, docetaxel, pembrolizumab patients.
2. interstitial pneumoniae, performed external radiation therapy in chest
3. sign of bacterial of viral infection patients.
4. pregnant or lactational patients
5. other cancer
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyasu Kawai
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Email n-kawai@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyasu Kawai
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Nephro-urology
Zip code
Address kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan
TEL 052-853-8266
Homepage URL http://www.med.nagoya-cu.ac.jp/uro.dir/
Email n-kawai@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences.
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization none

Other related organizations
Co-sponsor Toyota Kosei Hospital, Anjo Kosei Hospital, Kainan Hospital.
Name of secondary funder(s) none

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学病院(名古屋市)、豊田厚生病院(豊田市)、安城更生病院(安城市)、海南病院(弥富市)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 20 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037420

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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