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

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 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


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

Value
https://center6.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