A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy (TOP1)

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer
• Intervention / Treatment: Procedure: Type of omentectomy

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 Type: Interventional
• Enrollment (Anticipated): 418
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han Liang, Master; Phone Number: 1061 +86 022 23340123; Email: tjlianghan@126.com
• Study Contact Backup: Name: Bin Ke, Doctor; Phone Number: +86 13622036809; Email: binke@tmu.edu.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Hospital
      • Contact: Han Liang, Master; Phone Number: 1061 +86 022 23340123; Email: tjlianghan@126.com
      • Contact: Bin Ke, Doctor; Phone Number: +86 13622036809; Email: binke@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; D2 radical gastrectomy with partial omentectomy	Procedure: Type of omentectomy; Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.
No Intervention: Control group; D2 radical gastrectomy with total omentectom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3 years relapse-free survival	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.	3 years

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The volume of intraoperative blood loss	The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters.	1 week
Postoperative morbidity	Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications.	1 month
The length of the operation	The length of the operation was defined as the time from first skin incision to wound closure. The length of the operation is recorded in minutes.	1 week
Postoperative hospital stay	Postoperative hospital stay was defined as the time from the date of operation to the date of discharge. The postoperative hospital stay is recorded in days.	3 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Study Chair: Han Liang, Master, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 15, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Prognosis; Gastric Cancer; Omentectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: E2019054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No