UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015076 |
|---|---|
| Receipt number | R000017524 |
| Scientific Title | Selective bladder preservation with curative intent consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer |
| Date of disclosure of the study information | 2014/09/12 |
| Last modified on | 2014/09/06 16:16:02 |
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Basic information
Public title
Selective bladder preservation with curative intent consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer
Acronym
Bladder preservation consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer
Scientific Title
Selective bladder preservation with curative intent consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer
Scientific Title:Acronym
Bladder preservation consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer
Region
| Japan |
Condition
Condition
Muscle-invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of selective bladder preservation therapy consisting of chemoradiotherapy plus partial cystectomy for muscle-invasive bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle-invasive bladder cancer-free survival in patients with bladder preservation
Key secondary outcomes
Cancer specific survival, Overall survival, Recurrence-free survival, bladder preservation rate, QOL in patients with bladder preservation, Clinical and pathological effect of TURBT + low-dose chemoradiation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Low-dose chemoratiation therapy
Partial cystectomy
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
Muscle-invasive bladder cancer (cT2-3N0M0)
No involvement of the bladder neck
Response to induction chemoradiation therapy
Key exclusion criteria
CIS
Unfit for low-dose chemoradiation therapy or radical surgery under general anesthesia due to complications
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Kihara |
Organization
Tokyo Medical and Dental University
Division name
Urology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5295
k-kihara.uro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhisa Fujii |
Organization
Tokyo Medical and Dental University
Division name
Urology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5295
Homepage URL
http://www.tmd.ac.jp/med/uro/practice/cure/pc.html
y-fujii.uro@tmd.ac.jp
Sponsor or person
Institute
Department of Urology, Tokyo Medical and Dental University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Tokyo Medical and Dental University Graduate School
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
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
| 2014 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 03 | 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
Management information
Registered date
| 2014 | Year | 09 | Month | 06 | Day |
Last modified on
| 2014 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017524
