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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014057
Receipt No. 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

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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
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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