Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Summary

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.

Eligibility

Inclusion Criteria:

1. Aged 18-75 years
2. 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);
3. 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;
4. Clinical stage T2-4aN0-3M0 (According to AJCC-8th TNM staging system);
5. Expected survival \> 6 months
6. No invasion to Z-line;
7. BMI (Body Mass Index) \< 30 kg/m2
8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc
10. Preoperative performance status (ECOG，Eastern Cooperative Oncology Group) of 0 or 1
11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
12. Sufficient organ functions
13. Written informed consent

Exclusion Criteria:

1. Preoperative examinations indicate regional fusion of enlarged lymph nodes (max diameter ≥ 3.0cm) or enlargment of spleen hilus lymph nodes
2. Women during pregnancy or breast-feeding
3. Synchronous or metachronous (within 5 years) malignancies
4. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated
5. Severe mental disease
6. Severe respiratory disease, FEV1 \< 50% of predicted
7. Severe hepatic and renal dysfunction
8. Unstable angina pectoris or history of myocardial infarction within 6 months
9. History of cerebral infarction or cerebral hemorrhage within 6 months
10. Continuous systemic steroid therapy within 1 month (except for topical use)
11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery
12. Patients are participating or have participated in another clinical trial (within 6 months)

Conditions2

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