A Trial of Total Versus Partial Omentectomy for Advanced Gastric Cancer in Gastrectomy

Last updated: September 26, 2019
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Gastric Cancer

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT04108494
E2019054
  • Ages 18-70
  • All Genders

Study Summary

The main purpose of this study is to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

Eligibility Criteria

Inclusion

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 pathologicallyconfirmed;

  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: T2-4aN0-+M0;

  11. Macroscopic types :Borrmann I-III;

  12. Not greater curvature tumor;

  13. No previous surgery for any abdominal disease, except an appendectomy forappendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previoushistory of peritonitis, pancreatitis;

  14. Karnofsky performance status (KPS)>60; Eastern Cooperative Oncology Group PerformanceStatus (ECOG): 0-1.

Exclusion

Exclusion Criteria:

  1. 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 systemicdiseases, 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 cardiacinsufficiency;

  3. Organ transplantation patients need immunosuppressive therapy;

  4. Severe recurrent infections were not controlled or with other serious concomitantdiseases;

  5. Patients got other primary malignant tumors (except curable skin basal cell carcinomaand 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, patientsparticipate 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.

Study Design

Total Participants: 418
Study Start date:
January 01, 2019
Estimated Completion Date:
December 31, 2025

Study Description

Surgical resection is the mainstay of treatment for gastric cancer. The extent of surgical resection includes total or subtotal gastrectomy, D2 lymphadenectomy, and prophylactic or therapeutic resection of the surrounding organs or tissues (e.g., omentum, peritoneum, etc). However, the oncologic importance of omentectomy during gastrectomy remains unclear. The European guidelines do not give any advice regarding omentectomy, whereas the most recent American guidelines advise to resect both the greater and lesser omentum. Alternatively, the Japanese gastric cancer treatment guidelines recommends preservation of the greater omentum at >3 cm from the gastroepiploic arcade for patients with T1-T2 tumors and total omentectomy for patients with T3-T4 tumors. 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 primary endpoint is the 3-year relapse-free survival rate and the secondary endpoints are 5-year overall survival, and postoperative morbidity.

Connect with a study center

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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