Skip to content

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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190126
Enrollment
12
Registered
2019-11-21
Start date
2020-04-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

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

Sponsors

Ohno Tatsuya
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 = 60ml/min SpO2 >=90 percent 7.Written informed consent to participate in this study

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
determine recommanded dose of S-1

Secondary

MeasureTime frame
Safety, Response rate, Progression free survival , Overall Survival

Contacts

Public ContactYosuke Miura

Gunma University Hospital

m15702011@gunma-u.ac.jp+81-27-220-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026