None listed
Conditions
Interventions
Drug : ? Arm A: neoadjuvant CCRT with weekly paclitaxel + carboplatin -> surgery
? Arm B: neoadjuvant chemotherapy with weekly paclitaxel + carboplatin -> surgery -> post op radiotherapy
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically diagnosed esophageal squamous cell carcinoma (T1N1,2 or T2-4aN1-2, excluding T1N0 & T2N0) (RECIST1.1 can participate without measurable lesion) 2) esophageal cancer with previously not treated with surgery , chemotherapy , or radiation therapy 3) Over 20 years old, under 75 years old 4) ECOG performance status 0, 1 5) Appropriate bone marrow, liver, new function - Bone marrow function: absolute neutrophil count (ANC) = 1.5 x 109 / L, platelet count = 100 x 109 / L, - hemoglobin = 10 g / dL - liver function: total bilirubin = 1.5 x upper normal limit, AST, ALT = 2.5 x Upper nomal limit, alkaline phosphatase = 2.5 x upper normal limit - renal function: serum creatinine = 1.5 x upper normal limit 6) Appropriate lung function - FEV1 (1 second forced expiratory volume)> 50% predicted value, DLCO(Diffusion lung capacity for carbon monoxide)> 50% predicted value 7) agree to participate in clinical trials and obtained written consent
Exclusion criteria
Exclusion criteria: 1) distant metastasis (M1 stage) 2) cervical esophageal cancer difficult to radical surgery (within18 cm from incisor) or gastric esophageal cancer (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival (1year DFS rate) | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate, response rate, metabolic response rate, pCR, overall survival, locoregional failure free survival, distant meta free survival, postoperative complication rate, post op 30days mortality, post op in-hospital mortality, toxicity of chemotherapy | — |
Countries
Korea, Republic of
Contacts
Public Contactbhumsuk Keam
Seoul National University Hospital
Outcome results
None listed