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

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 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


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

Value
https://center6.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