Gastric cancer
Conditions
Interventions
1:concurrent radiochemotherapy (IMR+Raltitrexed)
Sponsors
Zhongnan Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent signed.; 2. Age 18-70 years old, male and female; 3. Pathologically diagnosed as gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; did not receive neoadjuvant chemotherapy or radiotherapy before surgery;received the 2-3 cycles of chemotherapy of FOLFOX regimens or 1-2 cycles of XeLOX or SOX regimens after operation; 4. Received D0 or D1 operation, no tumor residual (R0); 5. Postoperative pathological stage of pT3N0, pT4N0 or any T, N1-2, without distant metastatic disease; 6. ECOG 0-2; 7. Normal blood analysis: WBC=3.5 X10^9/L, GRAN=2.0 X10^9/L = 2, Hb=90g/L, PLT=100 X10^9/L; 8. Liver function: ALT or AST is less than or equal to 2.5 times of the normal high value (ULN); bilirubin is less than 1.5*ULN, serum APK is less than 2.5 * ULN; 9. Renal function: serum creatinine is less than 1.5 * ULN, and creatinine clearance rate is more than 60ml/min; 10. No previous chemotherapy or radiation therapy history; 11. No organ transplant history; 12. Urine pregnancy test results are negative for women of childbearing age in the first 7 days and not in lactation before treatment; 13. Men and women of childbearing age agreed to adopt reliable methods of contraception for 30 days before, during and after the course of the study.
Exclusion criteria
Exclusion criteria: 1. Received D2 radical operation; 2. Tumor residual (R1/R2); 3. There was found evidence of distant metastasis (M1) or suspicious metastasis after examination; 4. Other cancer history, except skin basal cell carcinoma or cervix in-situ carcinoma; 5. Previously received chemotherapy or other systemic anticancer therapy, including cytotoxic drugs, targeted drugs; or had received abdominal radiotherapy; 6. Anticipate other clinical trials in four weeks before enrollment; 7. Severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes, severe cardiac arrhythmia, etc.; 8. Drug abuse history or alcohol addiction; 9. Active infection existed.10 with severe malnutrition or severe anemia; 11. Human immunodeficiency virus (HIV) infection; 12. Pregnancy (confirmed by serum or urine beta -HCG test) or during lactation; 13. Can not tolerate this study or may be allergic to the drug used in this study; 14. Persons who have no or restricted capacity for civil conduct; or have mental illness, whom the researchers believe can not fully understand the possible complications of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute toxic reaction;Chronic toxic reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 and 3 year local control rate;2 and 3 year progress-free survival rate;2 and 3 year overall survival rate; | — |
Countries
China
Contacts
Public ContactFuxiang Zhou
Zhongnan Hospital of Wuhan University
Outcome results
None listed