esophageal cancer
Conditions
Interventions
synchronous radiotherapy group:The primary radiotherapy and the chemotherapy will be started simultaneously (the gap must be within 7 days). Radiotherapy: Total 50.4 Gy, 1.8 Gy / f, 5 f / w
Chemotherapy: S-1 70 mg / m2 / d bid, d1-14
Nedaplatin 75 mg / m2 ,IV, d1, q21d, 4-6 cycles.
Chemotherapy group:S-1 70 mg / m2 / d, bid, d1-14
Nedaplatin 75 mg / m2 ,IV, d1, q21d , 4-6 cycles.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) patients are older than 18 years old, male or female, at least to a liquid diet; 2) the eastern United States tumor cooperation group (ECOG) score 0-2 (see Annex 1); 3) histology proved to be the primary treatment of esophageal squamous cell carcinoma; 4) the clinical stage was cTxNxM1, IVb (according to the staging of UICC/AJCC eighth, see Annex 2); 5) the baseline blood routine and biochemical indicators of the subjects were in accordance with the following criteria: - hemoglobin was greater than 80 g/L; - absolute neutrophil count (ANC) = 1.5 * 10^9/L; - platelet count is over 100 * 10^9/L; - total bilirubin is less than 1.5 times the upper limit of normal (ULN); - alanine aminotransferase and aspartate aminotransferase is less than 2.5 ULN; - international normalized ratio of prothrombin time and partial thromboplastin time is less than 1.5, in the normal range (1.2 times the normal limit to 1.2 times the upper limit of the normal value); - were less than 1.5 ULN; 6) the electrocardiogram was basically normal in the first 4 weeks of the group, and there was no obvious clinical symptom of heart disease; 7) barium meal lesion length is less than or equal to 10cm; 8) have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) patients with histology proved to be adenocarcinoma of the esophagus; 2) patients with known allergies to nedaplatin or fluorouracil, or metabolic disorders; 3) prior chemotherapy, radiotherapy, or targeted therapy; 4) prior use of other experimental drugs or in other clinical trials at the same time; 5) patients with complete or incomplete digestive tract obstruction, digestive tract active bleeding, perforation and so on; 6) serious liver disease (such as cirrhosis), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic disease patients; heart disease, clinical symptoms such as congestive heart failure, symptoms of coronary heart disease, drug refractory arrhythmia, or within 6 months had a myocardial infarction, or heart failure; 7) disorder of peripheral nervous system or with a history of obvious mental disorders or central nervous system disorders; 8) the activity period of clinical severe infection which is higher than level 2 of common adverse event evaluation standard (CTCAE); 9) patients suufered cancers other than esophageal cancer during the first five years of treatment, which exclued cervical carcinoma in situ, basal cell carcinoma and bladder epithelial tumor[including Ta and Tis]; 10) history of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation), or long term systemic steroid therapy. (short term users stop taking drugs for >2 weeks); 11) second primary tumor; 12) pregnant women, breast-feeding women, women of childbearing age and their spouses refusing to take effective contraception by contraception; 13) people without legal capacity, medical or ethical reasons for the impact of research continue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;3 year progression free survival;3 year overall survival;quality of life;Objective Response Rate;adverse reactions; | — |
Countries
China
Contacts
Public ContactRuitai Fan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed