non-squamous non-small-cell lung cancer
Conditions
Interventions
1)CBDCA (AUC6 day1) + Paclitaxel(200mg/m2 day1) + Bevacizumb (15mg/kg day1) q3weeks 2 cycles 2)CBDCA (AUC6 day1) + Paclitaxel(200mg/m2 day1) q3weeks 1cycle 3) Surgery
Sponsors
1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) 2) Age:20-74years old 3) ECOG PS: 0 or 1 4) Without prior anti-cancer therapy (Surgery,radiation and chemotherapy therapy ) 5) Patients with stage II/IIIA(>T2) 6) Operable patient 7) Adequate organ function 8) Written informed consent from the patient
Exclusion criteria
Exclusion criteria: 1) Pleural effusion, pericardial effusion and ascites to need treatment 2) Current or previous histoty of hemoptysis (2.5ml) due to NSCLC 3) Evidence of bleeding diathesis or hemoptysis 4) With great vessel invasion 5) Cavity in tumor 6) Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day) 7) Active concomitant malignancy 8) Severe complications a)Current or previous history of cerebrovascular disease b)Current or previous history of GI perforation c)Severe cardiac disease d)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis e)Traumatic fracture of unrecovery f) Uncontrollable peptic ulcer g)Uncontrollable hypertenson h)Uncontrollable infectious disease 9) History of severe allergic reaction with platinum drug ,chemotherapy drug or monoclonal antibody 10) Pregnant or breast-feeding females 11) Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| STEP1 Safety STEP2 Overall Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Complete Response Rate Complete Resection Rate Relapse Free Survival Rate(1year,2years) Overall Survival Rate(1year,2years) Adverse events Blood loss during Oparation /Operation Time | — |
Countries
Japan
Contacts
Public Contactkazuhito Funai
Hamamatsu University School of Medicine First Department of Surgery
Outcome results
None listed