Non-squamous Non-small-cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Written informed consent (2) Age: 20-74 years old (3)ECOG performance status of 0 or 1 (4) Life expectancy more than 3 months (5)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) (6)StageIV or postoperative recurrence non-squamous non-small cell lung cancer (7)cheno-naive patient (8)Measurable by RECST(ver 1.1) criteria. (9) If the patient underwent therapy, there should be the following interval between the therapy and the registration 1)immunotherapy and endcrintherapy ->3 weeks 2)Radiotherapy other than thoracic radiation ->2 week 3)Surgery ->4 weeks 4)Thoracic drainarge ->2 weeks 5)Open biopsy, treatment of injury ->2 weeks 6) Transfusion and growth factor ->2 weeks 7)Aspiration biopsy, CV-port reservation ->1 week (10) Adequate organ function
Exclusion criteria
Exclusion criteria: (1) brain metastasis (2) active concomitant malignancy (3) Current or previous history of hemoptysis or active hemosputum (4) evidence of bleeding diathesis or coagulopathy (5) Current or previous history of Pericardial effusion (6) superior vena cava syndrome (7) spinal cord compression (8) Current or previous (within the last 1 year) history of cerebrovascular disease (9) Traumatic fracture of unrecovery (10) History of active infection (11) The operation has been scheduled for the examination period (12) receiving anticoagulant drug(except Aspirin under 324mg/day) (13) Uncontrollable Gastrointestinal ulceration (14) Current or previous (within the last 1 year) history of GI perforation (15) Uncontrollable hypertension (16) severe cardiac disease (17)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan or X-ray (18)peripheral neuropathy > Grade2 (19) severe drug allergy (20) history of hypersensitivity of Taxans or alcohol and the medicine made of the polio castor oil content (21) treatment history of bevacizumab (22) History of pregnancy or lactation (23) No intention to practice birth control (24) those judged to be not suitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Progression free survival, Time to response, Response duration, Overall survival | — |
Countries
Japan
Contacts
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital Department of Respiratory Medicine