Clinical trial NCT04843215: A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer
Official title: A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastric Cancer
Prognosis
Omentectomy
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Cancer Hospital & Institute
name: Shanghai Zhongshan Hospital
name: Fujian Cancer Hospital
name: Fujian Medical University Union Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Harbin Medical University
name: Hebei Medical University Fourth Hospital
name: Wuhan Union Hospital, China
name: The First Affiliated Hospital with Nanjing Medical University
name: Changzhi People's Hospital
name: The First Affiliated Hospital of Air Force Medicial University
name: First Affiliated Hospital of Kunming Medical University
name: LanZhou University
name: Liaoning Cancer Hospital & Institute
name: The First Affiliated Hospital of Nanchang University
name: Shandong Provincial Hospital
name: West China Hospital
name: Xinjiang Medical University Cancer Hospital
name: Zhejiang Cancer Hospital
name: Chinese PLA General Hospital
name: Sun Yat-sen University Cancer Hosptial
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2021-04-13
Enrollment: 950
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: This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

Detailed 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.

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: 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.

Primary outcomes:
measure: Disease Free Survival(DFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival(OS)
timeFrame: 5 years
Other outcomes:
measure: The volume of intraoperative blood loss
timeFrame: 1 week
measure: Postoperative morbidity
timeFrame: 1 month
Locations:
city: Tianjin
country: China
facility: Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: