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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Apr 12, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical methods for patients with advanced gastric cancer, a type of stomach cancer. The goal is to see which approach—removing the entire omentum (a layer of fat in the abdomen) or just part of it—helps patients live longer after surgery. The trial is open to patients aged 18 to 70 who have already had a specific type of surgery to remove the stomach cancer and are in good enough health to tolerate more surgery. Participants must also agree to follow the study guidelines and are expected to undergo a chemotherapy treatment called XELOX after their surgery.

If you or a loved one qualify and decide to participate, you will be randomly assigned to one of the two surgical methods and monitored throughout the study. It’s important to know that this trial is currently looking for participants, so there may be an opportunity to contribute to important research in treating advanced gastric cancer. This trial excludes patients with certain serious health conditions or those who have had other types of cancer recently, ensuring that only those who are most likely to benefit from the study can participate.

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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.