Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

Not Applicable

Recruiting

• Conditions: Stomach Neoplasms

• Registration Number: NCT04710758
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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.

Detailed Description

Gastric cancer is a significant global health problem, especially in East Asia. With an increase in the incidences of proximal gastric cancer over the last decades, the value of total gastrectomy is more emphasized. Laparoscopic total gastrectomy (LTG) has become an attracting option for surgeons due to its well-known advantages. However, more evidence is needed to support the safety and efficacy of LTG in locally advanced gastric cancer.

Recently，a multicenter, open-label, noninferiority, randomized clinical trial (CLASS-02) launched by Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group compared the safety of LTG for clinical stage I gastric cancer with open total gastrectomy (OTG). The overall morbidity and mortality rates were 19.1% in the LTG group and 20.2% in the OTG group, which was not significantly different (rate difference, -1.1%). This study demonstrated that LTG can be safely performed by experienced surgeons for clinical stage I gastric cancer. However, there hasn't been any prospective randomized clinical trial study evaluating the safety and efficacy of LTG in advanced gastric cancer.

This CLASS-07 trial is a prospective, multicenter, randomized controlled trial for comparison of long-term outcomes between LTG and 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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-02
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Study Start: 2021-01-20
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1316

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	3 years	Overall survival (OS) was defined as the time from randomization to death from any cause

Secondary Outcome Measures

Name	Time	Method
3-year disease free survival rate	3 years	# of patients who are free of gastric cancer at 3 years out of all study patients
3-year overall survival rate	3 years	# of patients who are still alive at 3 years out of all study patients
Early mortality rate	30 days	The early mortality are defined as the event observed within 30 days following surgery, including intraoperative and postoperative death
Postoperative recovery course	30 days	Time to first ambulation, flatus, liquid diet, and soft diet are used to assess the postoperative recovery course, which is a composite outcome measure.
3-year recurrence pattern	3 years	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type
Early morbidity rate	30 days	The early morbidity are defined as the event observed within 30 days following surgery, including intraoperative and postoperative complications

Trial Locations

Locations (1)

ZhongShan hospital FuDan university; 🇨🇳 Shanghai, Shanghai, China