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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002508
Receipt No. 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

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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
Email

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
Email enokida@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Department of urology, Osaka Medical College
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003066

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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