Comparing total and partial omentectomy for advanced gastric cancer

A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)

This study is testing whether keeping the omentum during surgery for advanced gastric cancer can help patients live as long as those who have it removed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 950 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT04843215 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the impact of omentectomy on survival in patients with advanced gastric cancer who have undergone curative gastrectomy. Participants are randomly assigned to either total omentectomy or omentum preservation to assess the non-inferiority of the latter approach. The study aims to determine if preserving the omentum can provide similar survival outcomes compared to its removal in patients with T3-T4a gastric cancer. The trial is multicenter and prospective, involving multiple hospitals to enhance the robustness of the findings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with pathologically confirmed T3-T4a gastric cancer who are eligible for radical resection.

Not a fit: Patients with serious concomitant diseases, previous abdominal surgeries, or those who have undergone chemotherapy or radiotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to less invasive surgical options for patients with advanced gastric cancer, potentially improving their quality of life and survival rates.

How similar studies have performed: Previous studies have explored omentectomy in gastric cancer, but this specific comparison of total versus partial omentectomy is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);
2. Physical condition and organ function allows to tolerable abdominal surgery;
3. Willing and able to comply with the program during the study period;
4. Written informed consent provided;
5. ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed;
6. With more than a 6-month life expectancy;
7. No other serious concomitant diseases; Sufficient organ functions;
8. No previous history of chemotherapy or radiotherapy;
9. All patients accept 8 cycles XELOX chemotherapy regimen;
10. Clinical stage: T3-4aN0-+M0; 11 . Macroscopic types :Borrmann I-III;

12\. Not greater curvature tumor; with distal or total gastrectomy； 13. No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis; 14. Karnofsky performance status (KPS)\>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.

Exclusion Criteria:

Pregnancy or breast feeding; 2. Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency; 3. Organ transplantation patients need immunosuppressive therapy; 4. Severe recurrent infections were not controlled or with other serious concomitant diseases; 5. Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; 6. Psychiatric disease which require treatment; 7. Have the history of organ transplantation; 8. Within 6 months before study starts and in the process of this study, patients participate in other clinical researches. 9. Advanced gastric cancer with omentum invasion 10. Patients can't treated with XELOX after surgery; 11 . Macroscopic types : Borrmann IV; 12. Tumor invasion of adjacent organ (T4b) or with distant metastasis#M1 #; 13. Tumor invasion the greater curvature invasion.

Where this trial is running

Tianjin, Tianjin Municipality

• Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Han Liang, Master

Conditions: Gastric Cancer, Prognosis, Omentectomy