A safety confirmation study of hypofractioned carbon-ion radiotherapy with CDDP+S-1 chemotherapy for locally advanced non-small cell lung cancer - A phase I study of carbon-ion radiotherapy with CDDP+S-1 chemotherapy

Ohno Tatsuya0 个研究点目标入组 12 人开始时间: 2019年11月21日最近更新: 2023年10月17日

试验速览

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•1. Histologically and/or cytologically proven unresectable non-small cell lung cancer of which stage is IIIA, IIIB, or IIIC
•2. More than 20 years old, and less than 75 years old
•3. ECOG Performace Status (PS) 0-1
•4. The case at least more than three months survival is expected
•5. The case having a measurable lesion
•6. Meets the following criteria
•absolute neutrophil >=1500/mm3
•platelet count >=100,000/mm3
•hemoglobin >=9.0 g/dL
•AST and ALT <=2.5 X ULN
•total bilirubin <=4.5 X ULN
•eGFR >= 60ml/min
•SpO2 >=90 percent
•7.Written informed consent to participate in this study

•1. Interstitial pneumonia , fibroid lung confirmed by CT.
•2. Anti-side hilar lymph nodes metastasis, atelectasis, pleural effusion, abdominal dropsy, pericardial fluid which need drainage
•3. Patient with active double cancer.
•4. Patient with serious disease condition (uncontrollable angina cordis, cardiac infarction or heart failure within 3 months, uncontrollable hypertension, diabetes mellitus, etc)
•5. Pregnancy
•6. History of cisplatin or other platinum allergy
•7. History of S-1 allergy
•8. Patient with tumor invasion to heart, great vessels, trachea, esophagus, tracheal bifurcation or ipsilateral lung metastasis
•9. Patient with active HBV or HCV or HIV infection
•10. Patient with concurrent treatment including chemotherapy, immunotherapy, biological drug, and hormone treatment
•11. Considered as unfit by attending doctor

发起方

Ohno Tatsuya