A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer
• Interventions: Procedure: Type of omentectomy

• Registration Number: NCT04108494
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

The main purpose of this study is to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

Detailed Description

Surgical resection is the mainstay of treatment for gastric cancer. The extent of surgical resection includes total or subtotal gastrectomy, D2 lymphadenectomy, and prophylactic or therapeutic resection of the surrounding organs or tissues (e.g., omentum, peritoneum, etc). However, the oncologic importance of omentectomy during gastrectomy remains unclear. The European guidelines do not give any advice regarding omentectomy, whereas the most recent American guidelines advise to resect both the greater and lesser omentum. Alternatively, the Japanese gastric cancer treatment guidelines recommends preservation of the greater omentum at \>3 cm from the gastroepiploic arcade for patients with T1-T2 tumors and total omentectomy for patients with T3-T4 tumors. In order to evaluate the impact of omentectomy for advanced gastric cancer on patient survival, we designed this trial. Patients who received curative gastrectomy were divided into two groups based on whether they underwent omentectomy. The primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, and postoperative morbidity.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-15
• Study First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30
• Primary Completion: 2020-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 418

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Type of omentectomy	D2 radical gastrectomy with partial omentectomy

Primary Outcome Measures

Name	Time	Method
3 years relapse-free survival	3 years	Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

Secondary Outcome Measures

Name	Time	Method
5 years overall survival	5 years	Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China