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

JRCT ID: jRCTs031190126

Registered date:21/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 22/04/2020
• Target sample size: 12
• Study type: Interventional
• Intervention(s): treated by S-1 and cisplatin with concurrent carbon-ion radiotherapy

Outcome(s)

• Primary Outcome: determine recommanded dose of S-1
• Secondary Outcome: Safety, Response rate, Progression free survival , Overall Survival

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Ohno Tatsuya