Non-small cell lung cancer
Conditions
Interventions
Cisplatin and TS1 followed by TS1 the other trial of same chemotherapy with bevacizumab at same time
Sponsors
Department of Respiratory Medicine National Center for Global health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria for Pre-registration 1) Histologically or cytologically proven non-small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy. Treatments below are acceptable for pre-registaration a) Palliative Irradiation except primary tumor of lung more than 2 weeks ago b)First line treatment by epidermal growth factor receptor-tyrosine kinase inhibitors more than 2 weeks ago c)post-operation adjuvant therapy more than 6 months. 4)Eastern Cooperative Oncology Group performance status of 0-1 5)Age; > or = 20 years and < 75 years 6) Tumor has the evaluable lesion. 7) capable of oral intake 8) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count; > or = 3,000/mm3 b) Neutrophil count; > or = 1,500/mm3 c) Platelet count; > or = 100,000/mm3 d) Hemoglobin concentration; > or = 10.0g/dl e) Total bilirubin level; < or = 2.0 mg/dl f) Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L g) PaO2; > or = 60 Torr or SpO2; > or = 90% at room air h) Creatinine clearance; > or = 60mL/min 9) Estimating Survival more than 12 weeks 10)Written informed consent II)Eligibility criteria for registration 1) More than 2 cycles of induction chemotherapy 2) Response criteria of induction chemotherapy achieved more than and equal to SD. 3) Maintenance start within 6 weeks after start of TS1 of last cycle.
Exclusion criteria
Exclusion criteria: 1) History of allergic reaction for agents of present treatment 2) Severe myelosupperssion, renal dysfunction or hepatic dysfunction 3) Patients received post-operation adjuvant therapy within 6 months. 4) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 5) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 6) Diarrhea more than and equal to grade 2 7) Active infection more than and equal to grade 2 8) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 9) Symptomatic brain metastasis but eligible for controlled brain metastases 10) Patients required for continuing steroid therapy 11) Pregnant status or lactation 12) Uncontrolled psychiatric disease 13) Other ineligible status judged by medical oncologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival from the beginning of maintenance therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate by RECIST, Overall survival, Time to treatment failure, Adverse events, Quality of life, Efficacy predictive factors (Thymidylate synthase, Dihydoropyrimidine dehydrogenase, others) | — |
Countries
Japan
Contacts
Public ContactYuichiro Takeda
National Center for Global health and Medicine Department of Respiratory Medicine
Outcome results
None listed