UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002913 |
|---|---|
| Receipt number | R000003549 |
| Scientific Title | Multicenter study: Effect of combined therapy using balloon-occluded arterial infusion of anticancer agent with concurrent radiation for elderly patients (or renal failure) with locally invasive bladder cancer |
| Date of disclosure of the study information | 2009/12/17 |
| Last modified on | 2012/02/28 14:06:25 |
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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 elderly patients (or renal failure) with 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 elderly patients (or renal failure) with 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 | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The comparison of efficacy and safety between BOAI-CDDP/radiation therapy and total cystectomy for elderly patients (or renal failure) with locally invasive bladder cancer.
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
| 75 | years-old | <= |
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) patients older than 75 years old, or with renal failure
(3) Histological type should be urothelial cancer.
(4) Stage T2 or T3 muscle-invasive bladder cancer without distant metastasis.
(5) Eastern Cooperative Oncology Group (ECOG) performance status 0-2,
(6) 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
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
Sponsor or person
Institute
Department of Urology Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
1, A grant form Cancer treatment foundation
2, A grant form Kenzo Suzuki foundation
3, 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
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
大阪医科大学附属病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 17 | Day |
Last modified on
| 2012 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003549
