UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004039 |
|---|---|
| Receipt number | R000004865 |
| Scientific Title | Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors. |
| Date of disclosure of the study information | 2010/08/13 |
| Last modified on | 2013/04/10 14:55:10 |
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Basic information
Public title
Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors.
Acronym
THPMG
Scientific Title
Randomized Phase II trial of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors.
Scientific Title:Acronym
THPMG
Region
| Japan |
Condition
Condition
Upper urinary tract urotherial tumor
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy of single early intravesical administration of THP for prevention of recurrent bladder tumors following surgery for upper urinary tract urotherial tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bladder recurrence rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravesical administration of THP
Interventions/Control_2
control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We have to satisfy all the following basis.
1) The case that an agreement is obtained in a document about participation of the final examination
2) The case that it is diagnosed as upper urinary tract urotherial tumors pathologically
3) No previous treatments
4) No metastasis and radical operation
5) No concomitant bladder tumors and/or a previous history of bladder tumors
6) Patients who can take cystoscopy
7) ECOG performance status: 0-3
8) The case that follow-ups more than postoperative one year is possible at least
9) Patients who have adequate major organ functions and fulfill all of the following criteria
1.ALT (GPT)/AST(GOT) upper limit of normal range
2.serum Creatine <1.5mg/dl
3.WBC: more than 4,000/mm3
Hb: more than 10 mg/dL
Plt: more than 100000/mm3
4.Electrocardiograph: Normal
Key exclusion criteria
1)The patient having a grave complication
2) Active cancer except upper urinary tract urotherial tumors is the patient
3)In addition, the patient whom we intended for it, and it was judged judgment of a doctor to be inadequate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Arai |
Organization
Tohoku University School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7278
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Ito |
Organization
Tohoku University School of Medicine
Division name
Department of Urology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tohoku University School of Medicine,Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://jco.ascopubs.org/
Number of participants that the trial has enrolled
Results
Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group.
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
| 2005 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
J Clin Oncol 31:1422-1427.2013
Management information
Registered date
| 2010 | Year | 08 | Month | 13 | Day |
Last modified on
| 2013 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004865
