Non-small cell lung cancer
Conditions
Interventions
Radiotherapy: 2Gy, 5fr/week 6weeks, Total 60Gy Carboplatin: AUC 4, day 1, 15, 29 nab-Paclitaxel: dose of each level, day 1, 15, 29 Level 1: 60 mg/m2 Level 2: 80 mg/m2 Level 3: 100 mg/m2
Sponsors
Aomori Prefectural Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed non-small cell lung cancer. 2) Clinical Stage IIIA or IIIB. 3) No prior therapy for NSCLC. 4) V20 is 35% or less by CT simulation before enrollment. 5) At least one measurable lesion. 6) ECOG Performance status of 0-1. 7) Age of 20 to 74 years. 8) Sufficient major organ function as bellow. *White blood cell count >= 4,000 /mm3 *Neutrophil count >= 2,000 /mm3 *Platelet count >= 100,000 /mm3 *Hemoglobin >= 9.5 g/dL *total bilirubin <= 1.5 mg/dL *AST <= 100 IU/L *ALT <= 100 IU/L *Serum creatinine <= 1.5 mg/dL *PaO2 >= 70 Torr or more 9) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with T3N1. 2) Superior vena cava syndrome. 3) Contralateral hilar lymph node metastasis, malignant plueral, pericardial effusion, carcinomatous lymphangiosis. 4) Active double cancer. 5) Active infections requiring systemic treatment. 6) Severe concurrent disease (Pulmonary fibrosis or interstitial pneumonia, renal failure, hepatic failure, cerebrovascular disease, ischemic heart disease requiring treatment, arrhythmia, cardiac infarction within 6 months before enrollment, hemorrhagic peptic ulcer, poorly controlled diabetes). 7) Grade 2 or higher peripheral neuropathy. 8) Positive HBs antigen and/or HCV antibody. 9) History of Severe drug allergies. 10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy. 11) Physician concludes that the patient's participation in this trial is inappropriate.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events Treatment completion rate Response Rate 2-year survival rate Progression-free Survival Overall Survival | — |
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicities at each dose level | — |
Countries
Japan
Contacts
Public ContactYukihiro Hasegawa
Aomori Prefectural Central Hospital Department of Respiratory Medicine
Outcome results
None listed