UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010785 |
|---|---|
| Receipt number | 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 09:04:18 |
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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
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
uro051@poh.osaka-med.ac.jp
Sponsor or person
Institute
osaka medical college
department of urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012532
