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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010785
Receipt No. R000012532
Scientific Title Efficacy of neoadjuvant Gemcitabin-Cisplatin chemotherapy for upper urinary tract carcinoma - Randomized comtrolled traial
Date of disclosure of the study information 2013/05/23
Last modified on 2013/11/23

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Basic information
Public title Efficacy of neoadjuvant Gemcitabin-Cisplatin chemotherapy for upper urinary tract carcinoma - Randomized comtrolled traial
Acronym Efficacy of neoadjuvant Gemcitabin-Cisplatin chemotherapy for upper urinary tract carcinoma - Randomized comtrolled traial
Scientific Title Efficacy of neoadjuvant Gemcitabin-Cisplatin chemotherapy for upper urinary tract carcinoma - Randomized comtrolled traial
Scientific Title:Acronym Efficacy of neoadjuvant Gemcitabin-Cisplatin chemotherapy for upper urinary tract carcinoma - Randomized comtrolled traial
Region
Japan

Condition
Condition Uper urinary tract carcinoma wituout distant metastasis
Classification by specialty
Urology Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness and safty of neoadjuvant chemotherapy using gemcitabin and cisplatin for patients with uper urinary tract urotherial carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes overall survival
cancer specific survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 2 cycles of cisplatin at 70 mg/m2 on day2,and gemcitabine at 1000mg/m2 on Day 1, 8,15 before radical nephroureterectomy
Interventions/Control_2 immediate radical nephroureterectomy without neoadjuvant chemotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1: Histologically or radiologically confirmed uper tract utotherial carcinoma.
2: not required diagnostic ureteroscopy.
3: clinical stage anyT anyN M0 disease.
4: ECOG Performance Status 0-1.
5: No prior therapy(systemic chemotherapy, surgery, radiation, immunotherapy)
6: Required Initial Laboratory Values:
7: Life expectancy > 3 months
8: Sign informed consent of this trial
Key exclusion criteria 1)Serious active infection
2)Temperature(<38)
3)Serious intercurrent medical or psychiatric illness
4)Prior malignancy [the patient has been disease free under 5 years]
5)peripheral neuropathy
6)Drug allergy or Pre-existing
7)If female of childbearing potential, pregnancy test is possitive
8)Others; based on the physicians' judgement
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name haruhito azuma
Organization osaka medical college
Division name urology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL 072-686-1221
Email uro051@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazumasa komura
Organization osaka medical college
Division name urology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, JAPAN
TEL 072-686-1221
Homepage URL
Email uro051@poh.osaka-med.ac.jp

Sponsor
Institute osaka medical college
department of urology
Institute
Department

Funding Source
Organization osaka medical college
department of urology
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
2013 Year 05 Month 23 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 23 Day
Last modified on
2013 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012532

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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