Comparing laparoscopic and open surgery for advanced stomach cancer
Prospective Randomized Controlled Multicenter Clinical Trial For Comparison Of Long-term Outcomes Between Laparoscopic And Open Total Gastrectomy In Patients With Locally Advanced Gastric Cancer
This study is testing whether laparoscopic surgery is better than open surgery for people with advanced stomach cancer in terms of recovery and long-term health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1018 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04710758 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with locally advanced gastric adenocarcinoma who are eligible for total gastrectomy.
Not a fit: Patients with a history of upper abdominal surgery or those who have received prior treatments like chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that laparoscopic surgery is a safer and more effective option for patients with advanced gastric cancer.
How similar studies have performed: Previous studies have shown that laparoscopic total gastrectomy can be safely performed for early-stage gastric cancer, but this trial is novel as it focuses on advanced cases.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.