Comparing total and partial omentectomy for advanced gastric cancer surgery

A Single-center, Randomized, Controlled Trial to Evaluate Total Versus Partial Omentectomy for Advanced Gastric Cancer in Radical Gastrectomy

This study tests whether removing all or just part of the omentum during surgery for advanced stomach cancer helps patients live longer and have fewer complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 418 (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)
• Trial ID: NCT04108494 on ClinicalTrials.gov

What this trial studies

This trial evaluates the impact of total versus partial omentectomy on survival rates in patients undergoing surgery for advanced gastric cancer. Patients who have undergone radical resection will be divided into two groups based on the type of omentectomy performed. The primary focus is on the 3-year relapse-free survival rate, while secondary outcomes include overall survival at 5 years and postoperative complications. The study aims to clarify the oncologic significance of omentectomy in the surgical management of gastric cancer.

Who should consider this trial

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

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

Why it matters

Potential benefit: If successful, this study could provide clearer guidelines on the optimal surgical approach for improving survival in advanced gastric cancer patients.

How similar studies have performed: While there is ongoing debate regarding the extent of omentectomy, this specific comparison has not been extensively tested in prior studies, making it 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: T2-4aN0-+M0;
11. Macroscopic types :Borrmann I-III;
12. Not greater curvature tumor;
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:

1. 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

• Tianjin Medical University Cancer Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Study coordinator: Han Liang, Master

Conditions: Gastric Cancer, Omentectomy, Prognosis