UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019902 |
|---|---|
| Receipt number | 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 18:33:39 |
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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
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
j2c789@bma.biglobe.ne.jp
Sponsor or person
Institute
Department of Urology, Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022986
