UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014057
Receipt number R000016368
Scientific Title Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function
Date of disclosure of the study information 2014/06/01
Last modified on 2015/12/24 20:42:33

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Basic information

Public title

Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function

Acronym

Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function

Scientific Title

Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function

Scientific Title:Acronym

Administration of Carboplatin for the urothelial carcinoma patients with impaired renal function

Region

Japan


Condition

Condition

Urothelial carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To study the safety and efficacy of combination chemotherapy using Gemcitabine and Carboplatin in the urothelial carcinoma patients with impaired renal function

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse events / side effects including renal impairment

Key secondary outcomes

Progression-free survival
Response rate based on the RECIST criteria


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

A combination chemotherapy using Gemcitabine and Carboplatin

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1> Histologically or clinically confirmed urothelial carcinoma
2> Muscle invasive (T2 or more) or metastatic
3> Renal function of 30ml/min =< CCr =<60ml/min
4> Sufficient bone marrow, liver and cardiovascular function
5> Life expectancy of at least 3 months
6> 20-90 years old
7> written informed consent

Key exclusion criteria

1. patients with severe bone marrow suppression
2. patients with allergy to any platinum agents including Carboplatin, or Gemcitabine
3. patients during Pregnancy or Lactation, and with the hope of pregnancy
4. patients with severe liver dysfunction
5. patients with severe / uncontrollable infection
6. patients with active Chicken pox infection
7. patients with interstitial pneumonia and pulmonary fibrosis
8 patients who underwent radiation therapy for lung
9. Patients who progressed during prior chemotherapy using Gemcitabine/Carboplatin or Gemcitabine/CDDP
10. Otherwise, patients who are judged to be not eligible by attending doctors.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tohru Nakagawa

Organization

The University of Tokyo Hospital

Division name

Department of Urology

Zip code


Address

7-3-1 Hongo Bunkyo-ku Tokyo

TEL

03-3815-5411

Email

tohru-tky@umin.org


Public contact

Name of contact person

1st name
Middle name
Last name Tohru Nakagawa

Organization

The University of Tokyo Hospital

Division name

Department of Urology

Zip code


Address

7-3-1 Hongo Bunkyo-ku Tokyo

TEL

03-3815-5411

Homepage URL


Email

tohru-tky@umin.org


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

2014 Year 06 Month 01 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

Completed

Date of protocol fixation

2013 Year 01 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 30 Day

Last follow-up date

2015 Year 06 Month 18 Day

Date of closure to data entry

2015 Year 12 Month 24 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 24 Day

Last modified on

2015 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name