UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003146 |
|---|---|
| Receipt number | R000002796 |
| Scientific Title | neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer |
| Date of disclosure of the study information | 2010/02/08 |
| Last modified on | 2019/08/07 17:18:01 |
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Basic information
Public title
neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer
Acronym
neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer
Scientific Title
neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer
Scientific Title:Acronym
neoadjuvant combined chemotherapy with gemcitabine, cisplatin and zoledronic acid against muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objectives is to discuss the efficacy of triple drug conbinated neoadjuvant chemotherapy with gemcitabine (GEM), cisplatin (CDDP), zoredronic acid (Zometa) for bladder cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
safety
survival(over all survival, progression free survival)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 course per 3 weeks
GEM 800mg/m2 day1,8 , CDDP 70mg/m2 day2, Zometa 4mg day2
Total 2 courses
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
Pathological bladder cancer.
20 years old and older.
Performance Status(P.S.): 0-1
The function of key organs (bone marrow, liver and kidney) is fully conserverd.
Above 6 months survival is prosmising.
Key exclusion criteria
overt infection.
fever(>38 degree)
catastrophic complication
active double cancer
asymptomatic brain metastases
pleural effusion
pericarium
varicella
moror parallysis or peripheral nervedisorder
drug sensitivity
pregnant woman, and have possibility
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Matsubara |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Urology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 (Japan)
TEL
082-257-5242
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Mita, Kanao Kobayashi |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Urology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551 (Japan)
TEL
082-257-5242
Homepage URL
Sponsor or person
Institute
Department of Urology, Graduate School of Biomedical Sciences
Hiroshima University
Institute
Department
Personal name
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
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 08 | 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
| 2009 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2009 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002796
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
