UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosis
Title of the study (Brief title)	FDG-PET/CT assessment of response to everolimus in renal cell carcinoma
Region	Japan

Condition
Condition	advanced renal cell carcinoma (RCC)
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 (RCC) treated with everolimus following tyrosine kinase inhibitor (TKI) and radiological parameters obtained with FDG-PET/CT including maximum standardized uptake value (SUVmax) at baseline and change of SUVmax at four weeks after everolimus treatment onset.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between maximum standardized uptake value (SUVmax) at four weeks after everolimus treatment onset and Progression-free survival. SUVmax: the highest SUV in all RCC lesions in the individual patient
Key secondary outcomes	A.Relationship between radiological parameters (1)-(3) and clinical outcome as below is exploratory evaluated. 1. Progression-free survival 2. Overall survival Relationship between laboratory data and prognosis Safety (adverse events) and QoL Radiological parameters (1) FDG-PET/CT observation at baseline, SUVmax,(Sigma)TLG, and SUL, and tumor size TLG: Total Lesion Glycilysis(g)=SUVmean(g/ml) x Volume(ml) SUL (SUV corrected by lean body mass ) (2) FDG-PET/CT observation at 4W after treatment start, especially change in SUVmax, (Sigma)TLG, SUL, and tumor size. (3) Presence/absence of new lesion B. the association of prognosis and laboratory data C. change of QOL by everolimus treatment

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	Other
Interventions/Control_1	Design of this study is prospective, multi-centered, single arm, interventional phase II study. Only the patients who are planned to receive everolimus treatment are enrolled in this study, and the treatment with everolimus is performed within the label of the drug as daily medical practice. Therefore the study is non-interventional in terms of treatment with everolimus. However, because the second FDG-PET/CT for evaluation of treatment efficacy is beyond the daily medical practice, this study is interventional.
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 20 years old (2)Histologically confirmed advanced/recurrent RCC (3)Under or after treatment with 1st tyrosine kinase inhibitor (sorafenib, sunitinib, axitinib, or pazopanib) (4)Treatment with everolimus is scheduled and the dose of everolimus at start is more or 5.0mg/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 everolimus is given. (2)Prior treatment with more or 2 tyrosine kinase inhibitors (3)Prior treatment of treatment with mTOR inhibitors (temsirolimus or everolimus) (4)Prior treatment with chemotherapy with antitumor drug, regardless of cytokine therapy (5)Poorly-controlled diabetes mellitus (fasting blood glucose more than 150 g/dL) (6)Pregnant and/or nursing woman, possibility of pregnancy (7)History of organ transplantation (including bone marrow transplantation) (8)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	30

Research contact person
Name of lead principal investigator	Noboru Nakaigawa
Organization	Yokohama City University
Division name	Department of Urology
Address	3-9 Fukuura Kanazawaku Yokohama, Japan
TEL	045-787-2800
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 ama Kanazawku Yokohama. Japan
TEL	045-787-2679
Homepage URL
Email	nakaigan@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 05 Month 10 Day
Anticipated trial start date	2013 Year 08 Month 25 Day
Last follow-up date	2018 Year 05 Month 09 Day
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 08 Month 23 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=R000012888