UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The early assessment of the response to Nivolumab of renal cell carcinoma by FDG PET/CT
Title of the study (Brief title)	RCC PET/CT study: response to Nivolumab
Region	Japan

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

Objectives
Narrative objectives1	To test whether the assessment by FDG PET/CT at 4 weeks after treatment start predicts the therapeutic effect of nivolumab to advancer renal cell carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	To test the correlation between judging by FDG PET/CT at 4 weeks after treatment start and the evaluation of therapeutic effect based on RECIST using CT scan at 16 weeks. The criteria of judging by FDG PET/CT at 4 weeks Responder: the case who satisfies the following conditions 1) max SUVmax increases more or 20% 2)without new lesions Non-responder: the case who does not meet "responder" max SUVmax: the highest SUV in the individual patient
Key secondary outcomes	To evaluate the relation between the assessment by FDG PET/CT at 4 weeks and clinical outcome as below. 1. Progression-free survival 2. Overall survival 3. Response rate To search radiological parameter which predicts clinical outcome as below 1. Progression-free survival 2. Overall survival 3. Response rate To search clinical parameter which predicts clinical outcome as below 1. Progression-free survival 2. Overall survival 3. Response rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
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 nivolumab treatment are enrolled in this study, and the treatment with nivolumab is performed within the label of the drug as daily medical practice. Therefore the study is non-interventional in terms of treatment with nivolumab. 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 renal cell carcinoma (3) Received the treatment by nivolumab (4) More than one target lesion defined by RECIST (v1.1) (5) With written informed consent
Key exclusion criteria	Patients who meet any of the following are excluded from the study. (1) Poorly-controlled diabetes mellitus (fasting blood glucose >150mg/dL) (2) History of organ transplantation (including bone marrow transplantation) (3) 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 (4) Pregnant and/or nursing woman, possibility of pregnancy (5) Patient treated simultaneously by other antineoplastic therapeutic or therapy purposing antitumor effect except for nivolumab examples: chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, hyperthermia, surgery (6) any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size	45

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 2360004 Japan
TEL	045-787-2679
Email	nakaigan@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Noboru Nakaigawa
Organization	Yokohama City University Graduate School of medicine
Division name	Department of Urology
Address	3-9 Fukuura Kanazawaku Yokohama 2360004 Japan
TEL	045-787-2679
Homepage URL
Email	nakaigan@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Yokohama Coty Univeesity
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kanagawa Cancer Center Yokosuka Kyosai Hospital
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	2018 Year 10 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 07 Month 03 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2021 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2023 Year 10 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 28 Day
Last modified on	2018 Year 11 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039527