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

NCT00260884 | Completed Phase 3

• 1 other identifier: A1293
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• We expect to enter 50 patients per year and finish accrual of patient within 2.5 years.

Interventions

conventional gastrectomy or radical lymph node dissection BEHAVIORAL

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients is not adenocarcinoma of the stomach.
• distant metastatic disease.
• previous gastrectomy.
• older than 75 years.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Chew-Wun Wu, Ph.D.

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

• Su-Shun Lo, M.D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 2, 2005
• Study Start: October 1, 1993
• Study Completion: August 1, 2004
• Last Updated: December 2, 2005

Record last verified: 2005-12