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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002337
Receipt No. R000002860
Scientific Title Multicenter study: Effect of combined therapy using balloon-occluded arterial infusion of anticancer agent with concurrent radiation for locally invasive bladder cancer
Date of disclosure of the study information 2009/08/14
Last modified on 2012/02/28

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Basic information
Public title Multicenter study: Effect of combined therapy using balloon-occluded arterial infusion of anticancer agent with concurrent radiation for locally invasive bladder cancer
Acronym Effect of BOAI of anticancer agent with concurrent radiation for locally invasive bladder cancer
Scientific Title Multicenter study: Effect of combined therapy using balloon-occluded arterial infusion of anticancer agent with concurrent radiation for locally invasive bladder cancer
Scientific Title:Acronym Effect of BOAI of anticancer agent with concurrent radiation for locally invasive bladder cancer
Region
Japan

Condition
Condition Locally invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The comparison of efficacy and safety between BOAI-CDDP/radiation therapy and total cystectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes progression free survival
Key secondary outcomes Over all survival
Quality of life
incidence rate of adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 balloon-occluded-arterial-infusion (BOAI) of anticancer agent (cisplatin/gemcitabine), concomitant with radiation
Interventions/Control_2 Total cystectomy
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) Patients were informed of the investigational nature of the study and provided written informed consent before study enrollment.
(2) Histological type should be urothelial cancer.
(3) Stage T2 or T3 muscle-invasive bladder cancer without distant metastasis.
(4) Eastern Cooperative Oncology Group (ECOG) performance status 0-2,
(5) absolute neutrophil count (ANC) of 1,500/L, platelets 100,000/L, creatinine 1.0, bilirubin 3 times the institutional upper limit of the normal range, AST 4 times the institutional upper limit of the normal range,
Key exclusion criteria Patients who :
(1) had prior systemic therapy for bladder cancer (radiation or chemotherapy)
(2) has serious complication (including severe DM)
(3) other cancers.
(4) are pregnant or wish to have baby
(5) are unable to receive this treatment for some reason.
Target sample size 220

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhito Azuma
Organization Osaka Medical College
Division name Department of Urology
Zip code
Address 2-7 Daigaku-cho Takatsuki-city Osaka Japan
TEL 072-683-1221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruhito Azuma
Organization Osaka Medical College
Division name Department of Urology
Zip code
Address 2-7 Daigaku-cho Takatsuki-city Osaka Japan
TEL 072-683-1221
Homepage URL
Email

Sponsor
Institute Department of Urology Osaka Medical College
Institute
Department

Funding Source
Organization A grant from the OMC Science Frontier Program for the Promotion of Research in Osaka Medical College
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2009 Year 08 Month 14 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
2009 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 08 Month 14 Day
Last modified on
2012 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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