UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004039
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Tohoku University School of Medicine,Department of Urology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004865

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.