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

Phase 1

Recruiting

• Conditions: on-small cell lung cancer

• Registration Number: JPRN-jRCTs031190126
• Lead Sponsor: Ohno Tatsuya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
determine recommanded dose of S-1

Secondary Outcome Measures

Name	Time	Method
Safety, Response rate, Progression free survival , Overall Survival