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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)

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 Tatsuya

Gunma University Hospital

3-39-15, Showa-machi, Maebashi, Gunma

tohno@gunma-u.ac.jp

Miura Yosuke

Gunma University Hospital

3-39-15, Showa-machi, Maebashi, Gunma

+81-27-220-8000

m15702011@gunma-u.ac.jp

Recruiting

Nov. 21, 2019

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

Non-small cell lung cancer

treated by S-1 and cisplatin with concurrent carbon-ion radiotherapy

determine recommanded dose of S-1

Safety, Response rate, Progression free survival , Overall Survival

+81-27-220-8740

Oct. 23, 2019

No

none