Status:
RECRUITING
Multicenter Study on Laparoscopic Total Gastrectomy for Advanced Gastric Cancer
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Stomach Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
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 m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1018 Patients enrolled
Trial Details
Trial ID
NCT04710758
Start Date
January 20 2021
End Date
December 31 2028
Last Update
September 22 2025
Active Locations (1)
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1
ZhongShan hospital FuDan university
Shanghai, Shanghai Municipality, China, 200032