The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. The overall survival and free disease survival are primary outcomes, with postoperative complication, hospital charges, and life quality as secondary outcomes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Second Affiliated Hospital, Sun Yat-Sen University; Sixth Affiliated Hospital, Sun Yat-sen University; Third Affiliated Hospital, Sun Yat-Sen University
• Treatments: Oxaliplatin

Criteria

Inclusion Criteria:

• The informed consent has been obtained from the patient.

• With confirmed pathological diagnosis of gastric cancer and visible para-aortic lymph nodes metastasis.

• Endurable D2/D4 gastrectomy and neoadjuvant chemotherapy.

• With moderate/good ECOG health rating (PS): 0-1 score.

Exclusion Criteria:

• Pregnant woman or lactating woman.

• With confirmed distant metastasis in liver, lung, bones, or other organs.

• Intolerable operation or neoadjuvant chemotherapy.

• With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.

• With bad compliance or contraindication to enrollment.