UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An investigation of antitumor effectiveness using M-VAC/CaG prediction system in neoadjuvant chemotherapy for muscle invasive bladder cancer.
Title of the study (Brief title)	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	Wataru Obara
Organization	Iwate Medical University
Division name	Urology
Address	19-1 Uchimaru, Morioka, Iwate
TEL	0196515111
Email	watao@iwate-med.ac.jp

Public contact
Name of contact person	Yoichiro Kato
Organization	Iwate Medical University
Division name	Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spandidos-publications.com/10.3892/ol.2018.9330
Results
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