UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Title of the study (Brief title)	Prognostic evaluation with focus on renal function of molecular target drugs for Unresectable or Metastatic Renal Cell Carcinoma patients with Renal Dysfunction
Region	Japan

Condition
Condition	Renal cell carcinoma
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy and safety of sorafenib in patients with Renal cell carcinoma with impaired renal function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eGFR(every 4 weeks)
Key secondary outcomes	overall Survival Progression Free Survival(PFS) Response Rate(CR+PR) Safety To confirm the molecular target drug usage before and after

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 sorafenib
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)Histologically proven Renal cell carcinoma (2)Over 20yrs (3)PS:0-1(ECOG grade) (4)eGFR<90ml/min(including dialysis patients) (5)Surgically unresectable (6)Life Expectancy must be >=6 months (7)Adequate hematologic, hepatic and respiratory function (8)Interval of at least 2 weeks between prior treatment and start of present study (9)Written informed consent
Key exclusion criteria	(1)Presence or past history of interstitial pneumonia or pulmonary fibrosis or possible (2)Active infections(excluding viral hepatitis) (3)Severe cardiac disorder, renal disorder, liver disorder, ulcer with bleeding, intestinal tract paralysis, uncontrollable diabetes mellitus (4)Presence of pleural effusion or ascites requiring drainage (5)Presence of metastasis in central nerve system (6)Active double cancer except carcinoma in situ or intramucosal cancer(synchronous double or asynchronous double cancer with disease free duration to be within 3 years) (7)Pregnant females or nursing mothers who can not stop lactation.Patients or partners, who do not attempt to doing contraception during the study period. (8)Severe mental disorder (9)Severe drug hypersensitivity (10)As determined by the principal investigator or the sub-investigator the subject is not adequate to participate in the trial.
Target sample size	30

Research contact person
Name of lead principal investigator	Toshiro Suzuki
Organization	Shinshu University school of medicine
Division name	Department of Urology
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	+81263372661
Email	yokoso1046@shinshu-u.ac.jp

Public contact
Name of contact person	Toshiro Suzuki
Organization	Shinshu University school of medicine
Division name	Department of Urology
Address	3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL	+81263372661
Homepage URL
Email	yokoso1046@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University school of medicine
Institute
Department

Funding Source
Organization	Shinshu University school of medicine
Organization
Division
Category of Funding Organization	Other
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	2016 Year 04 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 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	2016 Year 04 Month 19 Day
Last modified on	2017 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025336