UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009682
Receipt number R000011356
Scientific Title Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
Date of disclosure of the study information 2013/01/04
Last modified on 2023/07/18 14:24:53

* 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 control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy

Acronym

Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy

Scientific Title

Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy

Scientific Title:Acronym

Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy

Region

Japan


Condition

Condition

Urothelial carcinoma of upper urinary tract

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intravesical recurrence rate

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

intravesical instillaiton 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

1)Obtained informed consent
2)Pathologically confirmed urothelial carcinoma
3)No previous treatment of upper urinary tract tumors
4)No metastasis and resectable tumors
5)No previous bladder tumors and concomitant bladder tumors
6)ECOG PS 0-3
7)Have sufficient major organ functions

Key exclusion criteria

1)Need adjuvant chemotherapy according to pathological result
2)Have active cancer except for upper urinary tract tumors
3)Inappropriate patients for this study judged by the physicians

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Yamamoto

Organization

Hyogo College of Medicine

Division name

Department of Urology and Kidney Transplant Center

Zip code

663

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6366

Email

shingoy@hyo-med.ac.jp


Public contact

Name of contact person

1st name Toru
Middle name
Last name Suzuki

Organization

Hyogo College of Medicine

Division name

Department of Urology and Kidney Transplant Center

Zip code

6638501

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6366

Homepage URL


Email

tosuzuki@hyo-med.ac.jp


Sponsor or person

Institute

Department of Urology and Kidney Transplant Center, Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Urology and Kidney Transplant Center, Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kobe city Medical Center General Hospital
Kobe City Nishi-kobe Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hyogo College of Medicine

Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo, japan

Tel

0798456265

Email

h-cresc@hyo-med.ac.jp


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

兵庫医科大学病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、神戸市立西神戸医療センター(兵庫県)、


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 04 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

No longer recruiting

Date of protocol fixation

2012 Year 07 Month 01 Day

Date of IRB

2018 Year 08 Month 02 Day

Anticipated trial start date

2012 Year 08 Month 22 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 03 Day

Last modified on

2023 Year 07 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011356


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name