UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neo-Adjuvant Chemotherapy plus nephroureterectomy in Kyoto University
Title of the study (Brief title)	NACNUK trial
Region	Japan

Condition
Condition	urothelial carcinoma of upper urinary tract
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the efficacy and safety of neoadjuvant chemotherapy with gemcitabine/CDDP or gemcitabine/CBDCA before radical nephroureterectomy against locally advanced urothelial carcinoma of upper urinary tract
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	3-year disease-free survival rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
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	neoadjuvant chemotherapy plus radical nephroureterectomy
Interventions/Control_2	radical nephroureterectomy
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 clinical diagonosis of invasive urothelial carcinoma of upper urinary tract (cT2-4 or cTxN+) by imaging and urinary cytology 2 cases without unresectable distant metastasis 3 cases that an radical operation under the general anesthesia is possible. 4 cases with primary urothelial carcinoma (cases with hirtory of non-muscle invasive bladder cancer can be registered.) 5 Performance status 0-1 6 Cases maintaining the functions of the main organs.
Key exclusion criteria	1 Pregnant or potentially women, nursing women 2 Patients with past history of radicalcystectomy 3 Patients with psychiatric diseases 4 Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size	80

Research contact person
Name of lead principal investigator	Osamu Ogawa
Organization	Graduate School of Medicine, Kyoto University
Division name	the Department of Urology
Address	Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3325
Email	ogawao@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yoshiyuki Matsui
Organization	Graduate School of Medicine, Kyoto University
Division name	the Department of Urology
Address	Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto, Japan
TEL	075-751-3337
Homepage URL
Email	ym1108@kuhp.kyoto-u.ac.jp

Sponsor
Institute	the Department of Urology, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	the Department of Urology, Graduate School of Medicine, Kyoto 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	2014 Year 05 Month 27 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 27 Day
Anticipated trial start date	2014 Year 07 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 27 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/icdr_e/ctr_view.cgi?recptno=R000016404