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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021805
Receipt No. R000025144
Scientific Title Survival benefit on platinum based adjuvant chemotherapy following radical cystectomy for muscle invasive bladder cancer
Date of disclosure of the study information 2016/04/07
Last modified on 2016/04/06

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Basic information
Public title Survival benefit on platinum based adjuvant chemotherapy following radical cystectomy for muscle invasive bladder cancer
Acronym Platinum based adjuvant chemotherapy following radical cystectomy
Scientific Title Survival benefit on platinum based adjuvant chemotherapy following radical cystectomy for muscle invasive bladder cancer
Scientific Title:Acronym Platinum based adjuvant chemotherapy following radical cystectomy
Region
Japan

Condition
Condition Muscle invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of the platinum-based adjuvant chemotherapy following radical cystectomy
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival
Key secondary outcomes Cancer-specific survival

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who performed the radical cystectomy for the invasive bladder cancer diagnosed with CT2-4aM0M0.
Key exclusion criteria The patients who have lymph node metastasis and distant metastasis.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitaka Shimizu
Organization Juntendo Nerima Hospital
Division name Urology
Zip code
Address Takanodai, 3-1-10, Nerima-ku, Tokyo
TEL 03-5923-3111
Email f_simizu@juntendo.ac.jo

Public contact
Name of contact person
1st name
Middle name
Last name Fumitaka Shimizu
Organization Juntendo Nerima Hospital
Division name Urology
Zip code
Address Takanodai, 3-1-10, Nerima-ku, Tokyo
TEL 03-5923-3111
Homepage URL
Email f_simizu@juntendo.ac.jp

Sponsor
Institute Juntendo Nerima Hospital
Institute
Department

Funding Source
Organization None
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
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 順天堂大学附属病院、帝京大学附属病院、杏林大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 07 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 Completed
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 04 Month 06 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025144

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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