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Recruitment status
Unique ID issued by UMIN UMIN000001979
Receipt No. 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

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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
Email 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
Email shinya.yamamoto@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002414

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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