Non-small cell lung cancer
Conditions
Interventions
TS-1:60mg/m2/day-80mg/m2/day
Sponsors
Department of Respiratory Medicine & Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese 2)Histologically or cytologically Proven non-small cell lung cancer 3)Stage IIIB with no induction radiation therapy,or Stage IV 4)Age range older than 75 5)No previous chemotherapy surgery or radiotherapy 6)Measurable by RECIST criteria 7)Adequate bone narrow,liver, and renal functions Hb:over9.0g/dl WBC:4000-12000mm3 Neutro:over2000mm3 PLT:over100000/mm3 T-Bil:underNUMx2 AST,ALT:under100IU Ccr:over40ml/min PaO2:over60mmHg 8)ECOG Performance status of 0-2 9)Life expectancy of 12 weeks or more 10)Nomal EKG 11)Written informed concent
Exclusion criteria
Exclusion criteria: 1)History of severe allergy 2)Received surgery or radiotherapy to primary region 3)Use of other clinical trial drugs or phenytoin warfarin or flucytosine 4)Serious infection,SIADH,vena cava superior syndrome 5)Serious medical complications 6)Massive pleural effusion,ascites and penicardial effusion requires drainage 7)Symptomatic brain metastasis 8)Require radiotherapy to primary region 9)Concomitant malignancy 10)Intention to be pregnant in the future 11)Other clinical difficulties to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival,Overall survival,Patient-Reported Outcome(PRO),Adverse events | — |
Countries
Japan
Contacts
Public ContactHisatsugu Goto
Institute of Health Biosciences,The University of Tokushima Graduate School Department of Respiratory Medicine & Rheumatology
Outcome results
None listed