Esophageal squamous cell carcinoma
Conditions
Interventions
Conventional fractionated radiotherapy group:61.2Gy/34Fx
Simultaneous chemotherapy group:Paclitaxel +5FU, qw×5 weeks, then adjuvant paclitaxel +5FU q4w×2 courses
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form in person; 2. Age of 18-75 years old, both sexes; 3. Histologically confirmed esophageal squamous cell carcinoma, initially treated (without surgery/radiotherapy/chemotherapy or targeted therapy); 4. Locally advanced: T2-4N0-1M0-1a,TxN1M0-1a, TxNxM1a (AJCC2002, Annex 1) (the relevant data in AJCC2009 staging were recorded); 5. Men or women of childbearing potential are willing to use contraception in the trial; 6, No serious hematopoietic function, heart, lung, liver, kidney dysfunction and immune deficiency; 7, White blood cell >=3X10^9/L; Hemoglobin >=9 g/dL; Neutrophils >=1.5X10^9/L; Platelet >=100X10^9/L; Total bilirubin < 1.5 times upper limit of normal; AST (SGOT)/ALT (SGPT) =<2.5 times upper limit of normal; Creatinine =<1.5 times upper limit of normal; 8. ECOG 0-2 (see Annex 2 for ECOG criteria); 9. The expected survival time is more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Complete obstruction of esophagus, inability to eat fluids, deep ulcer or perforation of esophagus or hematemesis; 2. Previously received radiotherapy and chemotherapy for esophageal cancer; Major surgery within 28 days prior to the start of study treatment; 4, There is a second primary tumor (skin basal cell carcinoma, cervical cancer in situ, and after treatment without tumor survival for more than 3 years except); 5. Use of other investigational drugs or participation in other clinical trials 30 days before randomization; 6. Pregnant, breastfeeding or fertile but not taking contraceptive measures; 7. Drug addicts, long-term alcoholics, and AIDS patients; 8. Uncontrollable seizures, or loss of insight due to mental illness; 9. Patients with liver, lung and other organ metastases; 10. The investigator considers it inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicators;Anti-tumor efficacy indicators; | — |
Countries
China
Contacts
Public ContactJialiang Zhou
Affiliated Hospital of Jiangnan University
Outcome results
None listed