UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001979 |
|---|---|
| Receipt number | R000002414 |
| Scientific Title | Phase II study of a combined Paclitaxel, Gemcitabine, and Cisplatin chemotherapy regimen for advanced urothelial carcinoma |
| Date of disclosure of the study information | 2009/05/18 |
| Last modified on | 2017/11/21 17:52:36 |
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Basic information
Public title
Phase II study of a combined Paclitaxel, Gemcitabine, and Cisplatin chemotherapy regimen for advanced urothelial carcinoma
Acronym
Phase II study of a TGP chemotherapy regimen for advanced urothelial carcinoma
Scientific Title
Phase II study of a combined Paclitaxel, Gemcitabine, and Cisplatin chemotherapy regimen for advanced urothelial carcinoma
Scientific Title:Acronym
Phase II study of a TGP chemotherapy regimen for advanced urothelial carcinoma
Region
| Japan |
Condition
Condition
advanced urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and toxicity of a combined Paclitaxel, Gemcitabine, and Cisplatin (TGP) regimen as 2nd, 3rd line chemotherapy for advanced urothelial carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
1) safety
2)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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Paclitaxel 80mg/m2; day 1, 8
Gemcitabine 1000mg/m2; day 1, 8
Cisplatin 50mg/m2; day 2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
PS 0-2
advanced urothelial carcinoma
Ccr: more than 50ml/min
Key exclusion criteria
no other active malignancy
Acute myocardial infarction within 3 months of this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukui Iwao |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Urology
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
ifukui@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yamamoto Shinya |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Urology
Zip code
Address
3-10-6, Ariake, Koto-ku, Tokyo
TEL
03-3520-0111
Homepage URL
shinya.yamamoto@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2009 | Year | 05 | Month | 18 | 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
Date of protocol fixation
| 2009 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2009 | Year | 05 | Month | 16 | Day |
Last modified on
| 2017 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002414
