UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multiinstitutional study on evaluation methods of renal function before and during chemotherapy for urothelial cancer
Title of the study (Brief title)	CURE study
Region	Japan

Condition
Condition	Unresectable or metastatic urothelial carcinoma treated with systemic chemotherapy
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this retrospective study, using medical records of urothelial cancer patients, the various evaluation methods of renal function and cut off level for decision making will be extensively reviewed. This study is conducted to test the effect of each evaluation method and cut off level on protocol modification, treatment response, adverse events and survival outcome of patients treated with systemic chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of dose modification in the 1st-line chemotherapy.
Key secondary outcomes	1. The rate of regimen modification in the 1st-line chemotherapy. 2. Response rate in the 1st-line chemotherapy. 3. Overall survival rate. 4. Cancer-specific survival rate 5. Frequency of adverse effects. 6. Response rate in the 2nd-line chemotherapy. 7. Response rate in the 3rd-line chemotherapy. 8. Correlation among the measured results in renal function by different methods.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with histologically diagnosed urothelial carcinoma (*). 2. Patients with unresectable or metastatic urothelial carcinoma. 3. Patients treated with the 1st-line systemic chemotherapy from January 1, 2004 to December 31, 2010. 4. Aged 20 or older. *) Include ureteropelvic cancer which clinically diagnosed as urothelial carcinoma by cytologic and imaging diagnosis.
Key exclusion criteria	1. Patients given the first systemic chemotherapy before December 31, 2003. 2. Patients with active cancers in other organs at the start of systemic chemotherapy.
Target sample size	370

Research contact person
Name of lead principal investigator	Hiroyuki Nishiyama
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3196
Email	nishiuro@md.tsukuba.ac.jp

Public contact
Name of contact person	Daishi Ichioka
Organization	Faculty of Medicine, University of Tsukuba
Division name	Department of Urology
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3223
Homepage URL
Email	daichioka@yahoo.co.jp

Sponsor
Institute	Department of Urology, Tsukuba University Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tsukuba Clinical Research & Development Organization
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	2012 Year 04 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 03 Month 23 Day
Anticipated trial start date	2012 Year 04 Month 01 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://academic.oup.com/jjco/article-lookup/doi/10.1093/jjco/hyv082
Results
Other related information	Retrospective cohort study

Management information
Registered date	2012 Year 03 Month 29 Day
Last modified on	2018 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008979