Laparoscopic D2 Distal Gastrectomy Following Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancers

Summary

Gastric cancer is the third major cancer of global cancer-related death. In China, the early diagnosis rate of gastric cancer is relatively low, and most patients are with locally advanced tumor stage. The neoadjuvant chemotherapy (NAC) can bring the survival advantage for gastric cancer patients with locally advanced tumor stage. The primary goal of NAC is to control the micrometastasis and/or progression of the primary lesion in order to improve potential of radical gastrectomy. NAC is recommended for patients with locally advanced stage (T2-4Nx) according to the latest NCCN Gastric Cancer Guidelines.

Laparoscopy distal gastrectomy (LDG) can achieve a better postoperative short-term recovery than the traditional open distal gastrectomy (ODG), which can reduce the intraoperative blood loss and to shorten the postoperative hospital stay. Therefore, Enhanced Recovery After Surgery program of gastric cancer surgery recommends the use of minimally invasive surgery. For long-term survival outcomes, there is limited evidence supported that laparoscopic gastrectomy is comparable open gastrectomy. Therefore, due to the lack of high-quality prospective clinical trial results, whether advanced tumor is suitable for laparoscopic surgery is still controversial. Therefore, some multi-center prospective randomized controlled trials have been carried out, compared safety and long-term survival outcome between laparoscopic and open gastrectomy in locally advanced gastric cancer patients. CLASS-01 trials reported that for locally advanced gastric cancers, laparoscopic D2 distal gastrectomy is safe and feasible.

Patient's surgical tolerance and stress response may be inhibited after the treatment of NAC. The aim of this trial is to confirm the safety of laparoscopy distal D2 radical gastrectomy for the treatment of after neoadjuvant chemotherapy gastric cancer patients (cT3-4a, N+, M0) in terms of postoperative complications.

Conditions

• Complications, Postoperative
• Surgery--Complications
• Cancer of Stomach
• Chemotherapy Effect

Interventions

PROCEDURE

Laparoscopic D2 distal gastrectomy

Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Southern Medical University, China

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Harbin Medical University

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Sir Run Run Shaw Hospital

  collaborator OTHER

• West China Hospital

  lead OTHER

Principal Investigators

• Jian-Kun Hu, M.D. Ph.D. · West China Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-31

Primary Completion

2020-04-30

Completion

2023-04-30

Countries

• China

Study Locations