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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Unresectable or metastatic renal cell carcinoma | ||
Classification by specialty |
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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 |
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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 | |||
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Interventions/Control_7 | |||
Interventions/Control_8 | |||
Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
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Results Delayed | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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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 |