A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843215
• Other study ID #: E20210171
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Han Liang, Master
• Phone: +86 022 233401 23
• Email: tjlianghan[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

Description:

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 purpose of this study is to prove the non-inferiority of omentum preservation compared with omentectomy in patients with T3-T4a gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 950
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Type of omentectomy
Experimental group D2 radical gastrectomy with partial omentectomy. Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.

Locations

Country	Name	City	State
China	Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (23)

Lead Sponsor

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Beijing Cancer Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Changzhi People's Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Fujian Cancer Hospital, Fujian Medical University Union Hospital, Harbin Medical University, Hebei Medical University Fourth Hospital, LanZhou University, Liaoning Tumor Hospital & Institute, Shandong Provincial Hospital, Shanghai Zhongshan Hospital, Sun Yat-sen University Cancer Hosptial, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital with Nanjing Medical University, West China Hospital, Wuhan Union Hospital, China, Xijing Hospital of Air Force Military Medical University, Xinjiang Medical University Cancer Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Disease Free Survival(DFS)	Disease Free Survivalof the Participants	3 years
Secondary	Overall Survival(OS)	Overall Survival of the Participants	5 years