Non-Squamous Non-Small-Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) 2)Patients with stage IIIa or IIIb(UICC-7)However,"T3N1"is excluded 3)Patients with measurable lesion(RECIST ver.1.1) 4)Age:20-74years old 5)ECOG PS 0-1 6)Patients without previous treatment for NSCLC 7)If the patient underwent therapy, there should be the following interval between the therapy and the registration -Open biopsy,Treatment of injury->2 weeks -Aspiration biopsy,->1 week 8)Sufficient organ function neutro>=1500/mm3 Plt >=100000/mm3 Hb >=9.0g/dl T-bil <= 1.5mg/dl GOT/GPT <= 99IU/L Cr >= 1.5mg/dl SpO2 >= 95% or PaO2>=70mmHG FEV1.0 >=1.0L PT-INR<=1.5 Proteinuria <=1+ 9)Patients are expected to live over 3 months 10)Written IC
Exclusion criteria
Exclusion criteria: 1)History of active double cancer within 5 years 2)Overt infection 3)History of hemoptysis 4)With great vessel invasion 5)Cavity in tumor 6)Receiving anticoagulant drug(except Aspirin within 324mg/day) 7)Uncontrollable Gastrointestinal ulceration 8)Current or previous(within the last 1 year)history of GI perforation 9)Severe cardiac disease 10)History of Arterial thromboembolism within 1year 11)Interstitial pneumonia or pulmonary fibrosis detectable on X-ray 12)Peripheral neuropathy > Grade2 13)Major surgical procedure 14)With a history of drug sensitivity 15)History of pregnancy or lactation 16)No intention to practice birth control 17)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year survival rate Complete resection rate RFS DFS PFS pRR Safety | — |
Countries
Japan
Contacts
The Tokyo Cooperative Oncology Group Clinical Study Promotion Agency