Clinical trial NCT04108494: A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy
Official title: A Single-center, Randomized, Controlled Trial to Evaluate Total Versus Partial Omentectomy for Advanced Gastric Cancer in Radical Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Omentectomy
Prognosis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 3 years relapse-free survival
timeFrame: 3 years
Secondary outcomes:
measure: 5 years overall survival
timeFrame: 5 years
Other outcomes:
measure: The volume of intraoperative blood loss
timeFrame: 1 week
measure: The length of the operation
timeFrame: 1 week
measure: Postoperative hospital stay
timeFrame: 3 months
measure: Postoperative morbidity
timeFrame: 1 month
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Han Liang, Master
role: STUDY_CHAIR
References: