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.
This is a prospective, multi-centers, open-label, single-arm study, and the aim of this trial is to evaluate the safety of laparoscopic distal D2 radical gastrectomy for the treatment of locally advanced gastric cancer (cT3-4a, N-/+, M0) after neoadjuvant chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGSouthwest Hospital, the Third Military Medical University
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGGuangdong General Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGHarbin Medical University
Harbin, Heilonngjiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGFirst Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING...and 6 more locations
Postoperative overall morbidity rate
The proportion value will be calculated by the number of patients with any operative complication as the numerator and the number of patients undergoing surgical treatment as the denominator.
Time frame: Postoperative 30 days
Postoperative mortality rate
Mortality will be calculated as the ratio between the number of patients who died as numerator and number of all patients undergoing surgical treatment as the denominator.
Time frame: Postoperative 30 days
R0 resection rate
Number of patients underwent gastrectomy for the denominator, number of R0 resection patients is numerator, the ratio is the R0 resection rate. The definition of R0 resection is according to the Japanese gastric cancer treatment guidelines 2014 (ver. 4)(Gastric Cancer. 2017 Jan;20(1):1-19.).
Time frame: The day of surgery
Completion rate of laparoscopic surgery
Ratio will be calculated with the number of patients complete the laparoscopic gastrectomy as the numerator, and number of all patients undergoing laparoscopic surgical treatment as the denominator.
Time frame: The day of surgery
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