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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019902
Receipt No. R000022986
Scientific Title An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Date of disclosure of the study information 2015/11/23
Last modified on 2018/09/08

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Basic information
Public title An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Acronym An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Scientific Title An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Scientific Title:Acronym An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Region
Japan

Condition
Condition Muscle-invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 An investigation of the efficacy of neoadjuvant chemotherapy for muscle-invasive bladder cancer using prediction systems in comparison with historical controls.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The primary endpoints of this study are accuracy and efficacy of prediction systems, proportion of achieving significant tumor shrinking (>60%) by either or both of the two regimens with intention-to-treat compared with that of historical controls.
Key secondary outcomes The secondary endpoint is the overall survival between the patients of this prospective study and the historical controls.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Based on the results of the prediction score and patient's wishes the patients were allocated into four treatments; neoadjuvant M-VAC, neoadjuvant CaG, operation or radiation therapy without neoadjuvant chemotherapy
Interventions/Control_2
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Samples had been confirmed histologically as urothelial carcinoma of the bladder are selected for this study.
No node metastasis through computed tomography from their chest to pelvis and magnetic resonance imaging of their abdomen and pelvis at clinical stages T2aN0M0 to T4aN0M0 (Stage II-III) and were expected to undergo radical cystectomy without prior radiation therapy.
No serious abnormality in renal, hepatic or hematologic function and an Eastern Cooperative Oncology Group performance status (PS) judged to be <=2.
Key exclusion criteria 1) The case with serious complications
2) The case with active double cancer
3) The case with pregnancy, lactation or possibility of pregnancy
4) The case with drug allergy for G-CSF
5) The case with drug allergy for M-VAC or CaG
6) The case without the selection criteria
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Obara
Organization Iwate Medical University
Division name Urology
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 0196515111
Email watao@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoichiro Kato
Organization Iwate Medical University
Division name Urology
Zip code
Address 19-1 Uchimaru, Morioka, Iwate
TEL 0196515111
Homepage URL
Email j2c789@bma.biglobe.ne.jp

Sponsor
Institute Department of Urology, Iwate Medical University
Institute
Department

Funding Source
Organization Department of Urology, Iwate Medical University
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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.spandidos-publications.com/10.3892/ol.2018.9330
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 Completed
Date of protocol fixation
2011 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 23 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022986

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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