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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.

Phase 2
Recruiting
Conditions
nresectable or metastatic renal cell carcinoma
Registration Number
JPRN-UMIN000030972
Lead Sponsor
Department of Radiology, University of Yamanashi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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