Squamous cell lung cancer
Conditions
Interventions
Nedaplatin 80mg/m2 d1 q3w until PD TS-1 was administered at fixed dose based on the body surface area(BSA) of the patient. BSA<
1.25 m2 80mg/day BSA 1.25-1.5 m2 100mg/day BSA>
1.5 m2 150mg/day d1-14 q3w until PD
Sponsors
Toho university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologivally confirmed Stage3B/4 squamous cell lung cancer. 2)Patients who previously untreated whit systemic chemotherapy. 3)With one or more measurable disease based on Response Evaluation Criteria In SolidTumors(RECIST)ver1.1. 4)No radiotherapy other than thoracic radiation within 2 weeks No operation within 4 weeks No pleuodesis,pleural drainage etc.within 2 weeks No aspiration biopsy cytology within 1 weeks 5)Eastern Cooperative Oncology Group(ECOG)Performance Status of 0-2. 6)Adequate function of vital organs,including normal hematopoietic function,normal liver function and normal renal function as evidenced by the following data. Neutrocyte>=155/mm3 Hemoglobin>=9.0g/dL Platelet count>=75,000/mm3 Aspartate aminotransferase and alanine aminotransferase<100IU/I Total bilirubin<=1.5mg/dL Serum creatinine<=1.5mg/dL PT-INR<1.5 Urine protein<=+1 SpO2>=90% 7)A life expectancy of more than 3 months. 8)all patuebts provided written informed consent before initiation of study-related procedures.
Exclusion criteria
Exclusion criteria: History of active double cancer within 5 years. 2) Severe infection 3) History of hemoptysis with 2.5mL or more. 4) Continued bloody phlegm. 5) Received anticoagulant drug(including Aspirin over 325mg/day) within the past 10 days. 6) Perforation of the digestive tract or history of the perforation of the digestive tract within the past one year. 7) Severe comorbidity (heart failure Tendency to hemorrhages uncontrollable hypertension, uncontrollable diabetes, etc) 8) Arterial thromboembolism and Venous thromboembolism within the past one year. 9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 10) Planning of surgery or thoracic radiotherapy during the trial. 11) Major surgical procedure 12)With a history of drug sensitivity. 13)Pregnant or lactating women or those who declined contraception. 14) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival Progression free survival Time to responce Safety QoL | — |
Countries
Japan
Outcome results
None listed