Non small cell lung cancer
Conditions
Interventions
Carboplatin (day 1, AUC=5) and nab-Paclitaxel(day 1, 8, 15, 70mg/m2) Q4weeks, maximum 6 courses.
Sponsors
NPO Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed advanced non-squamous non-small-cell lung cancer 2) Clinical stage III (not amenable to curative radiation), IV or recurrent disease 3) patients without prior chemotherapy or curative radiotherapy for lung cancer 4) aged 20 - 74 years old 5) No matter EGFR or EML4-ALK mutation 6) patients who have at least one or more measurable lesion by RECIST v.1.1 7) ECOG (Eastern Cooperative Oncology Group) PS 8) Adequate organ function and laboratory findings as below(within 14 days prior registration); - WBC > 3,000/mm3 - neutrophil > 1,500/mm3 - platelet > 100,000/mm3 - hemoglobin > 9.0g/dl - AST, ALT < 100IU/L - total bilirubin < 1.5mg/dl - Ccr >45mL/min(Cockcloft-Gault mothod) - SpO2 > 90%(room air) 9) Life expectancy more than 2months 10) Symptomatic brain metastasis is allowed,if symptoms are comtrolled (14 days after surgery and/or radiotherapy) 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with serious infection and/or serious complications(gastrointestinal bleeding, or cardiac disorder, etc) 2) Patients with interstitial pneumonia (by Chest X-P) 3) Patients with prior radiotherapy to primary and /or target region. 4) Patient who is with contraindications to paclitaxel or carboplatin. 5) History of hypersensitivity for albumin products 6) History of poorly controlled pleural effusion,pericardial effusion and ascites 7) Patients with severe renal dysfunction 8) Patients with symptomatic brain metastases 9) Patients with active double cancer less than 5 years disease free period 10) History of Bone-marrow transplantation 11) History of Peripheral blood stem cell transplantation(PBSCT) 12) Patients who declined contraception. 13) Patients with uncontrollable diabetes or hypertension 14) Patients with hepatic cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month PFS rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS, overall survival, response rate, desease control rate, toxicities, 1-year survival rate, QOL | — |
Countries
Japan
Contacts
Public ContactYasuko Ichikawa
Teikyo University, School of Medicine Department of Medical Oncology
Outcome results
None listed