UMIN-CTR Clinical Trial

Basic information
Public title	Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Acronym	Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Scientific Title	Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Scientific Title:Acronym	Effect of immunotherapy on oncological and patientst reported outcomes in patients with urothelial cancer
Region	Japan

Condition
Condition	Urothelial carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigate effects of immunotherapy on oncological and patient reported outcomes inpatients with urothelial cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Effects of immunotherapy on oncological outcomes inpatients with urothelial cancer
Key secondary outcomes	Effects of immunotherapy on patient reported outcomes inpatients with urothelial cancer

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
Interventions/Control_1	Treatment group: Patients received immunotherapy for UC
Interventions/Control_2	Control group: Standard chemotherapy: Patients received either gemcitabine 800 mg/m2 on days 1, 8, and 15 plus cisplatin 70 mg/m2 (GCis) on day 2 every 3 wk, or gemcitabine 800 mg/m2 on days 1, 8, and 15 plus carboplatin (GCb) at an area under the curve of 4 according to the Calvert formula on day 2 every 3 wk, for two to four cycles. GCarbo is selected based on renal function (eGFR <60 mL/min/1.73m2) or presence of frailty.
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	Urothelial cancer who need systemic therapy or immunotherapy
Key exclusion criteria	History of severe cardiac conditions, such as angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study. History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. History of drug, alcohol, or substance abuse within the 6 months before Visit 1. Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to therapy and QoL
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki Univ.
Division name	Urology
Zip code	036-8562
Address	Hirosaki
TEL	+81172395091
Email	shingorilla2@gmail.com

Public contact
Name of contact person	1st name Shingo Middle name Last name Hatakeyama
Organization	Hirosaki Univ.
Division name	Urology
Zip code	036-8164
Address	5 zaifu-chou, Hirosaki Japan
TEL	0172-39-5091
Homepage URL
Email	shingoh@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki Univ.
Institute
Department

Funding Source
Organization	Hirosaki Univ.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hirosaki University Graduate School of Medicine
Address	5 Zaifu-chou
Tel	0172-33-5111
Email	rinri@hirosaki-u.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	2019 Year 12 Month 01 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	2019 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2019 Year 12 Month 01 Day
Last follow-up date	2024 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 30 Day
Last modified on	2020 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044174