Non-small cell Lung Cancer
Conditions
Interventions
Daily administrations: S-1 is administered orally twice daily after morning and evening meals at a dose of 40-60 mg (80-120 mg/day), depending on the BSA from days 1 to 28, which is followed by 14
Sponsors
North Japan Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed NSCLC 2)Unresectable or reccurent NSCLC 3)With or without measurable lesions 4)With at least 1 prior chemotherapy 5)Age of 20 years or older 6)ECOG performance status 2 or less 7)With adequate major organ functions within 14 days before randomization, as defined below: *White blood cell count >= 3,000/mm3 *Neutrophil count >= 1,500/mm3 *Platelet count >= 100,000/mm3 *Hemoglobin >= 9.0 g/dL *AST <= 2.5 x ULN *ALT <= 2.5 x ULN *Total bilirubin <= 1.5 mg/dL *PaO2 >= 60 Torr or SpO2 >= 94% *Estimated CCr >= 50 mL/min. 8)Sufficient oral intake 9)Written informed consent
Exclusion criteria
Exclusion criteria: 1)With interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray 2)Contraindication with S-1 3)With double cancer, multiple cancer 4)With malignant pleural, peritoneal effusion requiring drainage or pericardial effusion 5)With concurrent disease 6)With symptomatic brain metastasis 7)With severe diarrhea 8)Previous treatment with fluoropyrimidines such as S-1, UFT, 5-FU 9) Current use of flucytosine 10)Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 11)Physician concludes that the patient's participation in this trial is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Incidence of grade3 or higher Adverse Events) | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Progression-free Survival Overall Survival Completion rate of 1st course | — |
Countries
Japan
Contacts
Public ContactMakoto Maemondo
Miyagi Cancer Center Dept. of Respiratory Medicine
Outcome results
None listed