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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003738
Receipt No. R000004530
Scientific Title Multi-institutional clinical phaseII trial of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with invasive urothelial carcinoma of the urinary bladder
Date of disclosure of the study information 2010/07/01
Last modified on 2010/12/16

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Basic information
Public title Multi-institutional clinical phaseII trial of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with invasive urothelial carcinoma of the urinary bladder
Acronym Neoadjuvant chemotherapy with gemcitabine and cisplatin for invasive bladder urothelial carcinoma
Scientific Title Multi-institutional clinical phaseII trial of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with invasive urothelial carcinoma of the urinary bladder
Scientific Title:Acronym Neoadjuvant chemotherapy with gemcitabine and cisplatin for invasive bladder urothelial carcinoma
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 efficacy and safety of neoadjuvant GC(GEM+CDDP) chemotherapy in patients with invasive bladder cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate of neoadjuvant GC(GEM+CDDP)chemotherpy in patients with invasive bladder cancer
Key secondary outcomes Safety, Overall survival period, Cancer-specific survival period, Progression-free survival period

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 3 cycles of cisplatin at 70 mg/m2 on day2,and gemcitabine at 1000mg/m2 on Day 1, 8,15 before radical 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histologically confirmed muscle invasive transitional cell carcinoma of the bladder.
2)Clinical stage T2-T4a N0/X M0 disease.Medically appropriate candidate for radical cystectomy.
3)ECOG Performance Status 0-1.
4)No prior therapy(systemic chemotherapy, surgery, radiation, immunotherapy)
5)No previous history or concomitance of upper urinary tract cancer
6)Required Initial Laboratory Values:
7)Life expectancy > 3 months
8)Sign informed consent of this trial
Key exclusion criteria 1)Serious active infection
2)Temperature(<38)
3)Serious intercurrent medical or psychiatric illness
4)Prior malignancy [the patient has been disease free under 5 years]
5)Brain metastasis
6)Pleural effusion or ascites
7)Pericardial effusion
8)Varicella
9)peripheral neuropathy
10)Drug allergy or Pre-existing
11)If female of childbearing potential, pregnancy test is possitive
12)Others; based on the physicians' judgement
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyohide Fujimoto
Organization Nara Medical University
Division name Department of Urology
Zip code
Address Shijo-cho 840 Kashihara Nara Japan
TEL 0744-22-3051
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohide Fujimoto
Organization Nara Medical University
Division name Department of Urology
Zip code
Address Shijo-cho 840 Kashihara Nara Japan
TEL 0744-22-3051
Homepage URL
Email

Sponsor
Institute Nara Medical University
Department of Urology
Institute
Department

Funding Source
Organization Nara Medical University
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

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 06 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
2010 Year 06 Month 11 Day
Last modified on
2010 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004530

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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