Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer

* OBJECTIVES To determine in a prospective randomized clinical trial, the effect of extended lymph node dissection (R3 gastrectomy) versus conventional surgery (R0/1 gastrectomy) on tumor recurrence and survival in Chinese patients with advanced cancer of the stomach (adenocarcinoma invasion beyond submucosa). * STATISTICAL CONSIDERATIONS The major end points are disease free survival and survival. The log-rank test will be used as analytic method on disease-free survival and overall durvival. The follow-up time after treatment is five years. Previous experience provides an estimation of a 20% 5-year survival rate with conventional surgery for gastric cancer. Assuming that this new treatment (radical surgery) may increase the 5-year survival rate to 40%, we estimate that 118 evaluable patients are required to detected a significance at a of 0.05 level and power of 0.8 using a one tailed test. We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.

Sex

All

Minimum age

20 Years

Maximum age

75 Years

* Inclusion Criteria:

  1. Patients with histologically proven adenocarcinoma of the stomach.
  2. No clinical early stage stomach cancer (mucosa or submucosal invasion only).
  3. No esophageal invasion.
  4. No distant metastatic disease.
  5. No para-aortic, macrolymphadenopathy
  6. No N3, macrolymphadenopathy
  7. Suitable for gastric surgery with curative intent.
  8. Medically fit for surgery.
  9. No emergency resection required.
  10. No previous gastrectomy.
  11. Not older than 75 years.
  12. Signed informed consent form.
  13. No previous or concomitant other cancer.
* Exclusion Criteria:

  1. Patients is not adenocarcinoma of the stomach.
  2. distant metastatic disease.
  3. previous gastrectomy.
  4. older than 75 years.