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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
238
Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer
Number of harvested lymph nodes in D2 lymph node dissection
number of lymph nodes, pathologically proven after surgery
Time frame: 2 weeks after operation when the pathologic report is available
3 year progression free survival
PFS is defined as time from the point of randomization to objective tumor progression or relapse, or to death according to RECIST 1.1.
Time frame: 3 years after randomization
3 year relapse free survival
RFS is defined as time from the point of randomization to tumor relapse or death
Time frame: 3 years after randomization
Comparison of postoperative morbidity and mortality
Defined as the incidence of complications within 30 days after surgery, death rate within 90 days. Classification and severity of the complications shall be based on that of KLASS-02-RCT.
Time frame: 90 days after operation
Curative resection rate
Defined as a case where complete removal of all tumors were confirmed through gross or microscopic examination; negative resection margin was obtained; and, D2 lymph node dissection was performed.
Time frame: 2 weeks after operation when the pathologic report is available
Conversion to open surgery
Defined as a case which the laparoscopic surgery was converted to an open surgery in the operation time, because of reasons including combined organ resection due to adjacent organ invasion, severe intra-abdominal adhesion, or serious intraoperative bleeding.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.