Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    1316
  • sponsor
    Shanghai Zhongshan Hospital
Updated on 5 March 2021

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.

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.

Recentlya 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.

Details
Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Stomach Cancer, gastric neoplasm, gastric tumor
Treatment Open total gastrectomy, Laparoscopic total gastrectomy
Clinical Study IdentifierNCT04710758
SponsorShanghai Zhongshan Hospital
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 (ECOGEastern Cooperative Oncology Group) of 0 or 1
Preoperative ASA (American Society of Anesthesiologists) scoring: I-III
Sufficient organ functions
Written informed consent

Exclusion Criteria

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