Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer
CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between laparoscopic total gastrectomy (LTG) and open total gastrectomy (OTG) in patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0). The primary purpose of this study is to evaluate the overall survival and determine the efficacy of LTG compared with OTG for locally advanced gastric cancer. The second purpose is to evaluate the 3-year overall survival rate, 3-year disease free survival rate, morbidity and mortality rates, 3-year recurrence pattern and postoperative recovery course of the patients enrolled in this study.
• Aged 18-75 years
• Tumor located in the middle or upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers);
• Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma;
• Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
• Expected survival \> 6 months
• No invasion to Z-line;
• BMI (Body Mass Index) \< 30 kg/m2
• No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
• No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
⁃ Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
⁃ Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
⁃ Sufficient organ functions
⁃ Written informed consent