UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003738 |
|---|---|
| Receipt number | 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 20:17:20 |
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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
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
Sponsor or person
Institute
Nara Medical University
Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004530
