UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multi-institutional randomized Phase 2 trial of a treatment of nivolumab combined with stereotactic body radiotherapy for patients with unresectable or metastatic renal cell carcinoma.
Title of the study (Brief title)	NIVOSTRCC
Region	Japan

Condition
Condition	Unresectable or metastatic renal cell carcinoma
Classification by specialty	Urology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety and additional efficacy of SBRT on Nivolumab for unresectable or metastatic renal cell carcinoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate of non-irradiated lesion at 24 weeks after the starting of the treatment.
Key secondary outcomes	1,Reduction rate of non-irradiated lesion at 24weeks 2,Overall survival rate at 2-year 3,Cause-specific survival rate at 2-year 4,Occurrence rate of severe toxicities 5,Decrease of serum IAP level at 24 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	Patients receive 12cycles bi-weekly Nivolumab in total
Interventions/Control_2	Patients receive 12cycles bi-weekly Nivolumab in total and receive SBRT at the third cycle of Nivolumab
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)Cytologically or histologically confirmed renal cell carcinoma.or clinically judged as renal cell carcinoma. 2)At least two measurable lesions excluding lung lesion. 3)Radical operation not applicable 4)First-line molecular targeted drugs was finished, no prior indication of the other drug or when patient refuses 5)Immediate Radiotherapy not applicable 6)Aged 20 or more 7)ECOG Performance status of 0-2 8)Judgement by Radiation-oncologist for indication and safely of irradiation 9)Satisfication of the following criteria in the latest labo data within 7 days of the registration:1.WBC=3000 per mm3 or more,2.Hb=9.0g per dl or more, 3.PLT=50000 per mm3 or more, 4.Serum Creatinine=2.0mg per dl or less and eGFR 30mL/min or more 5.Total bililubine=1.5mg per dl or less, 6.GOT(AST)=100IU per L or less, 7.GPT(ALT)=100IU per L or less, 8.SpO2=93% or more(room air) 10)Written informed consent after enough explanation
Key exclusion criteria	1)Active double cancer(except for some early or cured cancer as followe:carcinoma in situ, mucosal cancer, stage I prostate, breast, or laryngeal cancer) 2)Serious heart disease,uncontrolled diabetes mellitus despite continuing treatment of insulin,cardiac infarction within 6 months before enrollment,uncontrolled hypertension,history of severe infections,watery diarrhea,paresis of intestine,ileus,autoimmune disease,other severe complications 3)Radiographically (chest X-P or CT image) confirmed interstitial pneumonitis or pulmonary fibrosis 4)Severe emphysema, chronic bronchitis, asthma 5)Continuous systemic administration of steroid 6)Severe mental illness 7)women who are or may be pregnant or in lactatoin 8)Unsuitable patients judged by the attending physician or radiation-oncologist(previous irradiation is ignored) 9)A history of pretreatment within 28 days before the start of first Nivolumab
Target sample size	100

Research contact person
Name of lead principal investigator	Hiroshi Onishi
Organization	Faculty of Medicine,University of Yamanashi
Division name	Department of radiology
Address	1110, Shimokato, Chuo-shi, Yamanashi, Japan
TEL	055-273-1111
Email	honishi@yamanashi.ac.jp

Public contact
Name of contact person	Kan Marino
Organization	Faculty of Medicine,University of Yamanashi
Division name	Department of radiology
Address	1110, Shimokato, Chuo-shi, Yamanashi, Japan
TEL	055-273-1111
Homepage URL
Email	marino@yamanashi.ac.jp

Sponsor
Institute	Department of Radiology, University of Yamanashi
Institute
Department

Funding Source
Organization	ONO PHARMACEUTICAL CO., LTD. Bristol-Myers Squibb K.K.
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	山梨大学医学部附属病院（山梨県）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 24 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 06 Day
Anticipated trial start date	2018 Year 01 Month 04 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	2018 Year 01 Month 24 Day
Last modified on	2018 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035299