Locally advanced non-small cell lung cancer
Conditions
Interventions
Nab-PTX and CBDCA are weekly administered as 1 cycle until 6 cycles. Concurrent thracic radiation therapy is performed from day 1 (2Gy/fr
5 days/1 week) until amount of 60Gy. Dose and schedule: Nab-PTX Dose of each level Day1 (q1w) CBDCA AUC 2 Day1 (q1w) Radiation 2GyX5days/week (total: 60Gy) Nab-PTX Dose of each levels: N
Sponsors
Gunma University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) pathologically confirmed NSCLC 2) locally advanced IIIA or IIIB NSCLC 3) Age 20-74 yrs 4) PS 0-1 5) Life survival > 3 months 6) Mesureable target lesion 7) No prior teatment such as chemotherapy or radiation therapy 8) Adequate organ function 9) Informed consent
Exclusion criteria
Exclusion criteria: 1) Interstitial pneumonia or pulmonary fibrosis 2) Pleural effusion, cardiac effusion or ascites requring drainage 3) Active double cancers 4) Uncotrollable angiona pectorias, cardian infarction, haear failure, diabetes mellitus, hypertension and severe infection 5) symptomatic brain metastasis 6) pregnancy 7) Alleary against CBDCA or nab-PTX 8) Inappropriate patients in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Primary endpoint; MTD and RD Phase II: Primary endpoint; Response rate at 1 month after initial chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: Secondary endpoint; safety, response rate Phase II: Secondary endpoint; overall survival, progression-free survival, safety | — |
Countries
Japan
Contacts
Public Contactkyoichi kaira
Gunma University Hospital TR center
Outcome results
None listed