esophageal cancer
Conditions
Interventions
control group:consolidation chemotherapy:Capecitabine +Cisplatin
experimental group:no consolidation chemotherapy
Sponsors
Departmen of Radiation Oncology ,Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years at the time of signing the informed consent form(ICF); 2. Subject has Eastern Cooperative Oncology Group(ECOG) performance status =2; 3. Subject has histologically confirmed esophageal squamous cell carcinoma; 4. Subject has stage T2N0M0-TxNxM1a-1b (2002 version 6 AJCC/UICC, M1b does not include lymph node metastasis beyond the celiac trunk and/or the supraclavicular region and viscera metastasis); 5. Subject must be inoperable medically or reject operation; 6. Subject must have not received chemotherapy, radiation or have attended other clinical trial; 7. Subject has adequate hematologic and end-organ function, as defined by the following laboratory results. (1) White blood cell =3.0*109 /L or Neutrophils =1.5 *109/L; (2) hemoglobin=90 g/L; (3) Platelet=100*109/L (4) total bilirubin=1.5 Upper Limit of Normal (5) Glutamic pyruvic transaminase and glutamic pyruvic aminotransferase=2.5 Upper Limit of Normal; (6) creatinine=1.5 Upper Limit of Normal. 8. Subject must be confirmed without severe disease ,immune deficiency or dysfunction of main organs, such as liver, kidney, heart and lung; 9. Life expectancy > 3 months; 10. Subject understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Exclusion criteria
Exclusion criteria: 1. Subject has malignancy history of other organ, except the curable non-melanoma skin cancer and carcinoma in situ of cervix (PFS=3years) 2. Subject has uncontrolled heart disease or cardiac (or myocardial) infarction in recent 6 months. 3. Subject has psychiatric history; 4. Subject is in pregnant and in lactation; 5. Subject has uncontrolled diabetes, hypertension and coronary heart disease; 6. Tumor that invades the trachea or aorta; 7. Esophageal tumor causes complete eating obstruction, accompanied by obvious perforation of esophagus, bleeding sign, perforation or bleeding; 8. Subject use oral or intravenous hormones simultaneously; 9. Subject has active infection; 10. Subject is considered unsuited to participate in the study by the doctor for some reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate;2-year local-regional control rate;toxicity related to the treatment;2 year diatance metastasis free survival rate; | — |
Countries
China
Contacts
Public ContactHong Ge
He'nan Cancer Hospital
Outcome results
None listed