Comparing laparoscopic and open surgery for advanced stomach cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CLASS-07 trial is a multicenter, randomized controlled trial aimed at comparing the long-term outcomes of laparoscopic total gastrectomy (LTG) versus open total gastrectomy (OTG) in patients with locally advanced gastric cancer. This study will evaluate overall survival, disease-free survival rates, morbidity and mortality rates, recurrence patterns, and postoperative recovery over a three-year period. By focusing on patients with clinical stage T2-4aN0-3M0 gastric cancer, the trial seeks to provide robust evidence regarding the safety and efficacy of LTG compared to OTG.

Why it matters

Who can join: the full rules

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)

Where it's running

• ZhongShan hospital FuDan university
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Yihong Sun, MD — Fudan University
• Study coordinator: Yihong Sun, MD
• Email: sun.yihong@zs-hospital.sh.cn
• Phone: 86-21-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.