eoadjuvant chemoradiotherapy vs. chemotherapy alone in locally advanced esophageal squamous cell carcinoma: randomized phase II study

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0002181

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 114

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

1) distant metastasis (M1 stage)
2) cervical esophageal cancer difficult to radical surgery (within18 cm from incisor) or gastric esophageal cancer (<2 cm from cardia) 3) Subject with a history of other malignant diseases within the last 3 years (allowed cured skin basal cell carcinoma, cervical intraepithelial cancer, early gastric cancer) 4) Active infection requiring antibiotic treatment 5) received chemotherapy 30 days 6) radiation therapy for chest or mediastinum in past 7) significant and ascites surgery 8) Pregnant lactating women 9) Subjects receiving organ transplants immunosuppressive 10) peripheral neuropathy NCI CTCAE v.4.0 grade 2 higher 11) clinically cardiopulmonary disease (eg, congestive heart failure, symptomatic coronary artery disease, myocardial infarction 6 months, arrhythmia uncontrolled, moderate to severe COPD, etc.) 12) vascular stenosis 13) who are not appropriate researchers>

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease free survival (1year DFS rate)

Secondary Outcome Measures

Name	Time	Method
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