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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003146
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Urology, Graduate School of Biomedical Sciences
Hiroshima University
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002796

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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