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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16);

• Physical condition and organ function allows to tolerable abdominal surgery;

• Willing and able to comply with the program during the study period;

• Written informed consent provided;

• ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed;

• With more than a 6-month life expectancy;

• No other serious concomitant diseases; Sufficient organ functions;

• No previous history of chemotherapy or radiotherapy;

• All patients accept 8 cycles XELOX chemotherapy regimen;

⁃ 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.

Locations
Other Locations
China
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
RECRUITING
Tianjin
Contact Information
Primary
Han Liang, Master
tjlianghan@126.com
+86 022 233401 23
Backup
Bik Ke, Doctor
binke@tmu.edu.cn
+86 022 23340123
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 950
Treatments
Experimental: Experimental group/D2 radical gastrectomy with partial omentectomy
Partial omentectomy with preservation of the greater omentum at \>3 cm from the gastroepiploic arcade.
No_intervention: Control group/D2 radical gastrectomy with total omentectom
Control group with total omentectomy
Related Therapeutic Areas
Sponsors
Collaborators: Hebei Medical University Fourth Hospital, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Air Force Medicial University, Sun Yat-sen University Cancer Hosptial, The First Affiliated Hospital of Nanchang University, West China Hospital, First Affiliated Hospital of Kunming Medical University, Peking University Cancer Hospital & Institute, Harbin Medical University, The First Affiliated Hospital with Nanjing Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhejiang Cancer Hospital, LanZhou University, Fujian Medical University Union Hospital, Shanghai Zhongshan Hospital, Xinjiang Medical University Cancer Hospital, Fujian Cancer Hospital, Changzhi People's Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Guangxi Medical University, Shandong Provincial Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov

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