UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survival benefit on platinum based adjuvant chemotherapy following radical cystectomy for muscle invasive bladder cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Fumitaka Shimizu
Organization	Juntendo Nerima Hospital
Division name	Urology
Address	Takanodai, 3-1-10, Nerima-ku, Tokyo
TEL	03-5923-3111
Email	f_simizu@juntendo.ac.jo

Public contact
Name of contact person	Fumitaka Shimizu
Organization	Juntendo Nerima Hospital
Division name	Urology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025144