Comparing total and partial omentectomy for advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the impact of omentectomy on survival in patients with advanced gastric cancer who have undergone curative gastrectomy. Participants are randomly assigned to either total omentectomy or omentum preservation to assess the non-inferiority of the latter approach. The study aims to determine if preserving the omentum can provide similar survival outcomes compared to its removal in patients with T3-T4a gastric cancer. The trial is multicenter and prospective, involving multiple hospitals to enhance the robustness of the findings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Han Liang, Master
• Email: tjlianghan@126.com
• Phone: +86 022 233401 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.