locally advanced non-small cell lung cancer
Conditions
Interventions
Chemoradiotherapy: Combination of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy 2Gy/day for 30 times Consolidation therapy: Combination of cisplatin plus nab-paclitaxel
Sponsors
Department of Medical Oncology, Kindai University, Faculty of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically documented non-small cell carcinoma of the lung. 2) Previously untreated Stage IIIA or IIIB 3) Unresectable 4) An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 5) Have measurable lesion 6) Patient aged 20-74 years old at the time of consent. 7) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1 8) Have adequate organ function within two week before study entry 9) Have signed an informed consent document
Exclusion criteria
Exclusion criteria: 1) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2) SVC syndrome 3) With active infection 4) With active double cancer. 5) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes, etc.) 6) Clinically significant drug allergy 7) Patients with steroid treatment. 8) Uncontrolled psychiatric disease. 9) Pregnancy or lactating patients 10) Positive serum HBs antigen or HCV antibody 11) Others
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| phase 1:safety, response rate, 2year survival rate, progression free survival, completion rate of chemoradiotherapy phase 2:safety, response rate, progression free survival, completion rate of chemoradiotherapy | — |
Primary
| Measure | Time frame |
|---|---|
| phase 1:determine the recommended dose phase 2:2year survival rate | — |
Countries
Japan
Contacts
Public ContactHidetoshi Hayashi
Kindai University Faculty of Medicine Department of Medical Oncology
Outcome results
None listed