Chemo-Naive Patients with Non-Squamous Non-Small-Cell Lung Cancer
Conditions
Interventions
Carboplatin AUC=5(day1)+S-1 80mg/m2 (day1~14)+Bevacizumab 15mg/kg (day1) q3weeks 3-6 cycles followed by Bevacizumab 15mg/kg (day1)+S-1 80mg/m2(day1~14) q3weeks until disease progression
Sponsors
Hyogo Cancer Center,Depatrment of Thoracic Oncology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with lung cancer which was pathologically proven non-squamous non-small cell lung cancer. 2)Patients with stage IIIb or IV(UICC-7) or recurrent disease after surgery who heve previously treated no chemotherapy. -Adjuvant and neo-adjuvant chemotherapy are considered as one regimen of chemotherapy. -Treatment by UFT is not considered as one regimen of chemotherapy. 3)Patiants who can take in drug orally 4)Patients with measurable lesion (RECIST ver 1.1) 5)If the patient underwent therapy, there should be the following interval between the therapy and the registration. -Radiotherapy other than thoracic radiation ->1week -Radiotherapy including pulmonary field->3months -Surgery,except CV-port reservation->4weeks -Thoracic drainarge->2weeks -Open biopsy, treatment of injury->2 weeks -Aspiration biopsy, CV-port reservation ->1 week 6) Age eligible for study-20-74 years old 7) ECOG PS 0-1 8)Sufficient organ function neutro>=2000/mm3 Plt >=100000/mm3 Hb >=9.0g/dl GOT/GPT <= ULNx2.5IU/L T-bil <= ULNx1.5mg/dl Cr. <= 1.5mg/dL Proteinuria <=(1+) or 2g/24hr SpO2 >= 92% or PaO2 >=60% 9)Patients are expected to live over 3 months 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis detected by chest CT 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of active infection or other serious complication 5)History of poorly controlled pleural effusion, pericardial effusion, and ascites 6)Treated by flucytosine(5-FC) 7)History of continuous (watery) diarrhea 8)History of ileus 9)History of severe heart disease(uncontrollable arrhythmia, uncontrollable angina pectoris, heart failure, etc) 10)Uncontrollable hypertension 11)Uncontrollable diabetes mellitus 12)Current or previous history of hemoptysis or hemosputum 13)Current or previous (within the last 1 year) history of symptomatic cerebrovascular disease 14)Current or previous (within the last 1 year) history of GI perforation 15)Symptomatic brain metastasis 16)Traumatic fracture of unrecovery 17)The operation has been scheduled during the examination period 18)Tumor invasive to the chest Laege bleed vessel.Cavity inbrain or lung tumor 19)Evidence of bleeding diathesis or coagulopathy 20)Thorombosis that need to treat 21)History of active double cancer with in 5 years 22)History of active psychological disease 23)History of pregnancy or lactation 24)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Progression free survival , Disease control rate, Toxicity | — |
Countries
Japan
Contacts
Public ContactYoshiko Urata
Hyogo Cancer Center Thoracic Oncology
Outcome results
None listed