UMIN-CTR Clinical Trial

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
Institute	The University of Tokyo Hospital
Institute
Department

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
URL(English)	https://upload.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

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