UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032805 |
|---|---|
| Receipt number | 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 14:24:57 |
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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
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/
n-kawai@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037420
