UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of a combined Paclitaxel, Gemcitabine, and Cisplatin chemotherapy regimen for advanced urothelial carcinoma
Title of the study (Brief title)	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	Fukui Iwao
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Urology
Address	3-10-6, Ariake, Koto-ku, Tokyo
TEL	03-3520-0111
Email	ifukui@jfcr.or.jp

Public contact
Name of contact person	Yamamoto Shinya
Organization	Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name	Urology
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)

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

Progress
Recruitment status
Date of protocol fixation	2009 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002414