completely resected non-small cell lung cancer
Conditions
Interventions
TS-1 (80-120mg/day x 14days, q21d X 16 courses) is administrated orally.
Sponsors
Division of General Thoracic Surgery, Keio University, School of Medicine,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) completely resected NSCLC 2) Ad, Sq, Large, AdSq 3) p-Stage IA (>=2.0cm), p-Stage IB 4) age ranged from 20 to 80 5) PS 0-1 (ECOG) 6) sufficient functionn of important organs a) WBC >= 4000/mm3 b) Neutro >= 2000/mm3 c) Platelet >= 100,000/mm3 d) Hb >= 9.0g/dl e) AST/ALT <= 2.5 fold of normal ranges in each institute f) T.Bil <= 1.5mg/dl g) Cr <= within normal limit h) CCr >= 50ml/min i) PaO2 >=70torr or SpO2>=92% 7) administration of TS-1 within 8 weeks after surgery 8) without previous treatment 9) with ability of oral intake 10) with written informed consent
Exclusion criteria
Exclusion criteria: 1) with interstitial change or fobrotic change on chest X ray film or chest CT scan 2) massive pleural effusion or ascites 3) with active double cancer 4) with intractable angina pectoris, myocardial infarction, cardiac failure, intractable diabetes mellitus, hypertension, sever infection, ileus, SVC syndrome, abnormal coagulability 5) watery diarrhea 6) pregnant, nursing woman or woman who is likely to be pregnant 7) men with partner willing to get pregnant 8) with severe drug allergy 9) with hypersensitivity to elements of TS-1 10) under medication with 5-FU 11) under medication with Flucytocine 12) doctor's decision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify the predictive factors for TS-1 sensitivity as adjuvant chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility and safety | — |
Countries
Japan
Contacts
Public ContactMitsutomo Kono
Keio University, School of Medicine Division of General Thoracic Surgery
Outcome results
None listed