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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030972
Receipt No. R000035299
Scientific Title 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.
Date of disclosure of the study information 2018/01/24
Last modified on 2018/01/24

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Basic information
Public title 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.
Acronym NIVOSTRCC
Scientific Title 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.
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Onishi
Organization Faculty of Medicine,University of Yamanashi
Division name Department of radiology
Zip code
Address 1110, Shimokato, Chuo-shi, Yamanashi, Japan
TEL 055-273-1111
Email honishi@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kan Marino
Organization Faculty of Medicine,University of Yamanashi
Division name Department of radiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 12 Month 06 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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