UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan multicenter prospective study: FDG PET/CT in the assessment of advanced renal cell carcinoma treated with sorafenib
Title of the study (Brief title)	Japan multicenter prospective study: FDG PET/CT Assessment of advanced Kidney cancer study (J-PEAK )
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to investigate the relationship of the clinical outcome of patients with advanced renal cell carcinoma treated with sorafenib and radiological parameters obtained with FDG-PET/CT including maximum standardized uptake value (SUVmax) at baseline and change of SUVmax at four weeks after treatment onset. This study is multicenter-study using PET/CT systems which quality is ensured by previous phantom study.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between radiological parameters (1)-(5) and Progression-free survival is exploratory evaluated. radiological parameters (1)FDG-PET/CT observation, especially SUVmax at baseline (2)Second FDG-PET/CT observation, especially change in SUVmax at 4W after treatment start. (3)Tumor size (4)Presence/absence of new lesion (5)Yokohama Response Criteria,especially the statistic difference between Intermediate responder and poor responder Yokohama Response Criteria is defined as below: (Ueno D et al. BMC Cancer 2012) Good responder: SUVmax decreases more or 20%, and total of tumor size shows shrinkage or no change at 4W Intermediate responder: SUVmax decreases less than 20%, and total of tumor size shows shrinkage or no change at 4W Poor responder: Any SUVmax, and the total of tumor size or number increase at 4W
Key secondary outcomes	Relationship between radiological parameters (1)-(5) and clinical outcome as below is evaluated. 1.Overall survival 2.Response rate 3.Disease control rate Radiological parameters (1)FDG-PET/CT observation, especially SUVmax, TLG, and SUL at baseline TLG: Total Lesion Glycilysis SUL: SUV corrected by lean body mass (2)Second FDG-PET/CT observation, especially change in SUVmax, TLG, and SUL at 4W after treatment start. (3)Tumor size (4)Presence/absence of new lesion (5)Yokohama Response Criteria Safety (adverse events)

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	FDG PET/CT at 4 weeks after treatment start
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	Patients who meet all of the following are eligible. (1)Over or 20 years old (2)Histologically confirmed advanced/recurrent RCC (3)No prior treatment with molecular targeted agents (tyrosine kinase inhibitors, mTOR inhibitors) or only prior treatment with cytokine therapies (4)Treatment with sorafenib is scheduled and the dose of sorafenib at start is more or 400mg/day. (5)More than one target lesion defined by RECIST (v1.1) (6)Major organ function conserved (7)Life expectancy of more or 12 weeks (8)With written informed consent
Key exclusion criteria	Patients who meet any of the following are excluded from the study. (1)Concurrent antitumor treatment other than sorafenib is given. (2)Prior treatment except cytokine therapies (3)Poorly-controlled diabetes mellitus (fasting blood glucose is more than 150 g/dL) (4)Pregnant and/or nursing woman, possibility of pregnancy (5)History of organ transplantation (including bone marrow transplantation) (6)History of malignancy except: (i)Curatively treated intraepithelial cervical cancer, basal cell carcinoma, superficial bladder cancer (Ta, Tis and T1). (ii)Patients who had been disease free more for than 3 years after curative therapy
Target sample size	50

Research contact person
Name of lead principal investigator	Noboru Nakaigawa
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Urology
Address	3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan
TEL	045-787-2679
Email	nakaigan@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Noboru Nakaigawa
Organization	Yokohama City University
Division name	Department of Urology
Address	3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, 236-0004 Japan
TEL	045-787-2679
Homepage URL
Email	nakaigan@med.yokohama-cu.ac.jp

Sponsor
Institute	Japan PET/CT Assessment of advanced Kidney cancer study group(J-PEAK group )
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2013 Year 01 Month 20 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 01 Month 11 Day
Anticipated trial start date	2013 Year 01 Month 21 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	2013 Year 01 Month 19 Day
Last modified on	2017 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011500