Status:
COMPLETED
Phase III Study OF the Gastric Surgery on Advanced Stage Gastric Cancer
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
* 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 a...
Detailed Description
\* TREATMENT PLAN Patients are randomized intraoperatively into arm I (conventional \[R0/R1\] gastrectomy) or arm II (extended radical \[R3\] lymph node dissection). Arm I: Resection of stomach, gre...
Eligibility Criteria
Inclusion
- Patients with histologically proven adenocarcinoma of the stomach.
- No clinical early stage stomach cancer (mucosa or submucosal invasion only).
- No esophageal invasion.
- No distant metastatic disease.
- No para-aortic, macrolymphadenopathy
- No N3, macrolymphadenopathy
- Suitable for gastric surgery with curative intent.
- Medically fit for surgery.
- No emergency resection required.
- No previous gastrectomy.
- Not older than 75 years.
- Signed informed consent form.
- No previous or concomitant other cancer.
Exclusion
- Patients is not adenocarcinoma of the stomach.
- distant metastatic disease.
- previous gastrectomy.
- older than 75 years.
Key Trial Info
Start Date :
October 1 1993
Trial Type :
INTERVENTIONAL
End Date :
August 1 2004
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00260884
Start Date
October 1 1993
End Date
August 1 2004
Last Update
December 2 2005
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