UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032805
Receipt number R000037420
Scientific Title Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.
Date of disclosure of the study information 2018/06/20
Last modified on 2018/05/31 14:24:57

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Basic information

Public title

Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.

Acronym

Randomized study as second-line chemotherapy in mUC patients.

Scientific Title

Randomized study as second-line chemotherapy in mUC patients between gemcitabine and docetaxel regimen and pembrolizumab.

Scientific Title:Acronym

Randomized study as second-line chemotherapy in mUC patients.

Region

Japan


Condition

Condition

metastatic urothelial carcinoma patients after treated first-line cisplatin based chemotherapy

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy as second-line treatment compared chemotherapy to immunotherapy using pembrolizumab.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

progression free survival

Key secondary outcomes

adverse events, overall survival, response to treatment, QOL after 2 cycles of treatment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

gemcitabine and docetaxel combination chemotherapy

Interventions/Control_2

immunotherapy using pembrolizumab

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

20 years-old <

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

The following World Health Organization criteria were met by all the enrolled patientsan adequate bone marrow reserve, reasonable hepatic function, and an estimated life expectancy of over 12 weeks. Ineligible patients included those with non-malignant systemic disease, such as active infection that precluded them from receiving therapy, or those with any clinically significant cardiac arrhythmia, and/or congestive heart failure. All patients provided written informed consent prior to this clinical trial. The institutional chemotherapy review boards (ethical committees) of Nagoya City University Hospital and Nagoya City University

Key exclusion criteria

1. allergy of gemcitabine, docetaxel, pembrolizumab patients.
2. interstitial pneumoniae, performed external radiation therapy in chest
3. sign of bacterial of viral infection patients.
4. pregnant or lactational patients
5. other cancer

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriyasu Kawai

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


Address

kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan

TEL

052-853-8266

Email

n-kawai@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriyasu Kawai

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Nephro-urology

Zip code


Address

kawasumi 1, mizuho-cho, mizuho-ku, Nagoya, Japan

TEL

052-853-8266

Homepage URL

http://www.med.nagoya-cu.ac.jp/uro.dir/

Email

n-kawai@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences.

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

none


Other related organizations

Co-sponsor

Toyota Kosei Hospital, Anjo Kosei Hospital, Kainan Hospital.

Name of secondary funder(s)

none


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

名古屋市立大学病院(名古屋市)、豊田厚生病院(豊田市)、安城更生病院(安城市)、海南病院(弥富市)


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 20 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

Preinitiation

Date of protocol fixation

2018 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2018 Year 06 Month 20 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 05 Month 31 Day

Last modified on

2018 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037420


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name