locally advanced gastric cancer
Conditions
Interventions
Research Group:docetaxel plus cisplatin regiment as adjuvant chemotherapy and concurrent chemoradiation regiment
Control Group:FOLFOX6 regiment as adjuvant and 5-FU/CF as chemoradiotherapy regiment
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Aged > 19 years; 3. Histologically proven gastric or gastroesophageal adenocarcinoma; 4. >= D2 lymph node dissection, curative gastrectomy; 5. Stage T4 with or without any positive LN (AJCC 2010), No distant metastasis(M0) and after D2 radical gastrectomy; 6. KPS>=70 or ECOG 0-2; 7. R0 resection; 8.Adequate bone marrow functions (WBC>=4.0*10^9/L; GRAN>=2.0*10^9/LHb>=90g/L, transfusion allowed, PLT>=100*10^9/L); 9. Not have Diseases of the blood system and uncontrolled severe cardiopulmonary concurren system disease; 10. Adequate renal functions(serum creatinine <=1.5*ULN); liver functions (serum bilirubin <=1.5*ULN, AST/ALT <=2.5 times(normal value), serum AKP<=2.5*ULN.
Exclusion criteria
Exclusion criteria: 1. pregnant or breast-feeding women; 2. Have received preoperative neoadjuvant therapy of gastric cancer; 3. Before or at the same time with other malignant tumor, and underwent chemotherapy, immune, and biological treatment and radiation therapy; 4. uncontrolled mental disease; 5. Concurrent serious systemic disease; 6. Active infection requiring antibiotics; 7. Resection margin (+) at permanent pathology; 8. Peripheral neuropathy symptoms, NCI class > 1; 9. severe malnutrition or severe anemia; 10. uncontrolled Primary brain tumors or the central nervous system disease; 11. cannot tolerate or with drug allergies; 12. Pathologic stage I-IIa or IV (according to AJCC 2010); 13. Inadequate surgery including D0, D1 resection, dissected LNs less than 12.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Local or regional control rate; | — |
Countries
China
Contacts
Public ContactFuxiang Zhou
Outcome results
None listed