UMIN-CTR Clinical Trial

Basic information
Public title	Study to evaluate the effectiveness and saftyof the mFOLFOX+bevacizumab combination therapy for bladder adenocarcinoma
Acronym	Study to evaluate the effectiveness and saftyof the mFOLFOX+bevacizumab combination therapy for bladder adenocarcinoma
Scientific Title	Study to evaluate the effectiveness and saftyof the mFOLFOX+bevacizumab combination therapy for bladder adenocarcinoma
Scientific Title:Acronym	Study to evaluate the effectiveness and saftyof the mFOLFOX+bevacizumab combination therapy for bladder adenocarcinoma
Region	Japan

Condition
Condition	bladder adenocarcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We perform mFOLFOX+bevacitumab therapy for patients with bladder adenocarcinoma and examine the effectiveness, safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	response rate
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of oxaliplatin, fluorouracil, levofolinate and bevacizumab
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	1.The patients who have a diagnosis of a bladder adenocarcinoma histologically 2.The patients who are resistant to clinical trial S1+CDDP for the bladder adenocarcinoma and GD therapy of 2nd line for the urothelial carcinoma. 3.The patients who do not use bebacizumab
Key exclusion criteria	1.Case with serious myelosuppression 2.Case with the diarrhea (stools watery) 3.Case who had a serious infection 4.A large quantity of ascitic fluid, case with the pleural effusion 5.Case with serious heart disease or the anamnesis 6.The case that overall status worsens 7.Case with severe dysesthesia with the functional disorder or the dysesthesia 8.A pregnant woman or the case that may be pregnant and nursing mother 9.It is a case with a history of hypersensitivity for an ingredient including, levofolinate, fluorouracil, oxaliplatin and other platinum
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Noriyasu Middle name Last name Kawai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan
TEL	052-853-8266
Email	n-kawai@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Noriyasu Middle name Last name Kawai
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Nephro-urology
Zip code	467-8601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku,Nagoya, Japan
TEL	052-853-8266
Homepage URL
Email	n-kawai@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Hospital
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	Nagoya City University Hospital Institutional Review Board
Address	Kawasumi 1, Mizuho-cho,Mizuho-ku,Nagoya
Tel	052-858-7215
Email	Clinical_research@med.nagoya-cu.ac.jp

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	2016 Year 02 Month 25 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	2
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	2014 Year 07 Month 01 Day
Date of IRB	2014 Year 07 Month 31 Day
Anticipated trial start date	2014 Year 08 Month 15 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024441