NCT04658589

Laparoscopic vs. Open Distal Gastrectomy After Neoadjuvant Chemotherapy

A Multicenter Prospective Phase II Comparative Study of Laparoscopic Versus Open Distal Gastrectomy After Neoadjuvant Chemotherapy for the Treatment of Locally Advanced Gastric Cancer Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (estimated)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial. 238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1/3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy. The primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.

Detailed description

The effect of neoadjuvant chemotherapy on locally advanced gastric cancer was confirmed from a prospective clinical trial. Oncologic safety and excellence of the laparoscopic gastrectomy surgery was recently established for locally advanced gastric cancer. However, neither technical nor oncologic stability was established for laparoscopic gastrectomy surgery after neoadjuvant chemotherapy. Anticipated benefits from laparoscopic gastrectomy surgery after neoadjuvant chemotherapy are as follows: 1) Reduced postoperative complications; 2) Reduced intra- or postoperative transfusion and patient's pain after surgery; 3) Enhance postoperative recovery (shortened hospitalization duration); 4) Facilitate completion rate of adjuvant chemotherapy. The study was designed as single-country, multi-center, open-labelled, randomized (1:1), phase II trial. 238 patients with medically and technically operable advanced gastric adenocarcinoma in middle or distal 1/3 of stomach are enrolled and randomly assigned to laparoscopic gastrectomy group and open gastrectomy group. 4 cycles of mFLOT chemotherapy will be conducted before and after gastrectomy. The primary objective of this study is comparison of D2 lymph node dissection compliance rate between open surgery group and laparoscopic surgery group after neoadjuvant chemotherapy.

Conditions

• Stomach Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic versus open distal gastrectomy	Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-01
• Completion: 2026-12-01
• First posted: 2020-12-08
• Last updated: 2020-12-08