UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002508 |
|---|---|
| Receipt number | R000003066 |
| Scientific Title | Effect of combined therapy using balloon-ocluded arterial infusion of cisplatin with concurrent radiation for locally invasive bladder cancer: multi-center study |
| Date of disclosure of the study information | 2009/09/17 |
| Last modified on | 2009/09/16 13:56:49 |
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Basic information
Public title
Effect of combined therapy using balloon-ocluded arterial infusion of cisplatin with concurrent radiation for locally invasive bladder cancer: multi-center study
Acronym
Effect of chemotherapy using cisplatin with concurrent radiation for locally invasive bladder cancer
Scientific Title
Effect of combined therapy using balloon-ocluded arterial infusion of cisplatin with concurrent radiation for locally invasive bladder cancer: multi-center study
Scientific Title:Acronym
Effect of chemotherapy using cisplatin with concurrent radiation for locally invasive bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We tested the usefulness of combined therapy using balloon-occluded arterial infusion of cisplatin with concurrent radiation in patient with locally advanced 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
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
| Medicine | Maneuver |
Interventions/Control_1
BOAI-CDDP arterial infusion + radiation
Dose: CDDP 100mg x 1 + radiation 60Gy follow up duration: 5 years
Interventions/Control_2
Radical cystectomy with/without neoadjuvant or adjuvant chemotherapy
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 who or whose family can agree with written informed consent
(2) patients with bladder cancer which is histologivally comfirmed urothelial cancer
(3) cTNM classification: T2-T3, N0, M0
(4) performance status: PS 0-2 (ECOG)
(5) patients who meet the following criteria
1. liver function; AST less than 2.5 times of the institutional upper limit of the normal range, total bilirubin less than; 2.0 times of the institutional upper limit of the normal range,
2. renal function; creatinin less than 1.5mg/dL,
3.cardiac function; tolerable function for the therapy,
4. bone-marrow; WBC more than 3,000/microL,
neutrophil more than 1,500/microL,
hemoglobin more than 10g/dL,
platelet more than 100,000/microL,
(6) regardless of age.
Key exclusion criteria
(1) Previous general treatment (radiation or chemotherapy) for the patients with bladder cancer.
(2) Patients who have severe complication (including serious diabetes) unable to be eligible for the study.
(3) Patients having another active cancer.
(4) Pregnant women, breast-feeding women, or women who will get pregnant.
(5) Others who are considered to be a ineligible for the study.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Enokida |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Urology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5395
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Enokida |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Urology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5395
Homepage URL
enokida@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Department of urology, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
鹿児島大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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 | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 16 | Day |
Last modified on
| 2009 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003066
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