UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030972 |
|---|---|
| Receipt number | 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 15:39:18 |
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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
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
marino@yamanashi.ac.jp
Sponsor or person
Institute
Department of Radiology, University of Yamanashi
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035299
