non-small cell lung cancer with two or more lesions including at least lung or pluera
Conditions
Interventions
Total 12 courses of Nivolumab(3 mg/kg,by 2weeks). Performing stereotactic body radiation therapy (more than 5 Gy/fraction(total biological effective dose of 40-55Gy within 2weeks) for lung or a pleura
Sponsors
Department of Radiology, University of Yamanashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cytologically or histologically confirmed non-small-cell lung cancer 2)At least two measurable lesions including at least one lung or thoracic lesion. 3)Radical radiotherapy not applicable 4)Aged 20 or more 5)ECOG Performance status of 0-2 6)Judgement by Radiation-oncologist for indication and safely of irradiation 7)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=100000 per mm3 or more, 4.Serum Creatinine=1.5mg per dl or less, 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 ai) 8)Written informed consent after enough explanation
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of cases with grade four/five or aggravation of two or more toxicity grade within 24 weeks after the start of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The reduction ratio in size of irradiated lesions and the non-irradiated lesion at 24 weeks after start of treatment. The change of the tumor marker level as of 24 weeks after start of treatment and stereotactic body radiotherapy. The expression ratio of PD-L1 in the tumor before the start of treatment. The ratio of case with one or two aggravation of toxicity grade within 24 weeks after the start of therapy. | — |
Countries
Japan
Contacts
Public ContactKan Marino
Faculty of Medicine, University of Yamanashi Department of Radiology
Outcome results
None listed