NCT03468712: CLASS-03a

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

Status unknown NA Last updated 5 September 2018

What this trial tests

NA trial testing Laparoscopic D2 distal gastrectomy in Complications, Postoperative in 166 participants. Status unknown.

Timeline

31 March 2018

Primary endpoint
30 April 2020

30 April 2023

Quick facts

Lead sponsor	West China Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	166
Start date	31 March 2018
Primary completion	30 April 2020
Estimated completion	30 April 2023
Sites	16 locations across China

Drugs / interventions tested

• Laparoscopic D2 distal gastrectomy

Conditions studied

• Complications, Postoperative — all drugs for Complications, Postoperative →
• Surgery--Complications — all drugs for Surgery--Complications →
• Cancer of Stomach — all drugs for Cancer of Stomach →
• Chemotherapy Effect — all drugs for Chemotherapy Effect →

Sponsor

West China Hospital

Who can join

Adults 18 to 75, any sex, with Complications, Postoperative or Surgery--Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of preoperative therapy on surgical outcomes of laparoscopic total gastrectomy for gastric/gastroesophageal junction cancer.
   Chen Y, Yang Z, Zhao M, Xu C, et al · · 2023 · cited 1× · PMID 37691897 · DOI 10.21147/j.issn.1000-9604.2023.04.03
2. The safety of laparoscopic D2 distal gastrectomy following neoadjuvant chemotherapy for locally advanced gastric cancer patients: a prospective multicenter trial (CLASS-03a)
   Yang K, Li S, Wang X, Li G, et al · · 2025