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NCT Number: NCT04843215

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

This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Liang Han

CONTACT

[email protected]

086-022-23340123 ext. 1061

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • 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.

Treatment and study plan

Type of omentectomy

Procedure

Experimental group D2 radical gastrectomy with partial omentectomy. Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.

Primary outcomes

  1. Disease Free Survival(DFS)

    Time frame: 3 years

    Disease Free Survivalof the Participants

Secondary outcomes

  1. Overall Survival(OS)

    Time frame: 5 years

    Overall Survival of the Participants

Other outcomes

  1. The volume of intraoperative blood loss

    Time frame: 1 week

    The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation. The Blood loss volume is recorded in milliliters.

  2. Postoperative morbidity

    Time frame: 1 month

    Postoperative morbidity was defined as the incidence rate of the postoperative complication. The postoperative morbidity were examined within 30 days after surgery. Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Bik Ke, Doctor

CONTACT

[email protected]

+86 022 23340123 ext. 1061

Han Liang, Master

CONTACT

[email protected]

+86 022 233401 23 ext. 1061

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Changzhi People's Hospital
  • Chinese PLA General Hospital
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Kunming Medical University
  • Fujian Cancer Hospital
  • Fujian Medical University Union Hospital
  • Harbin Medical University
  • Hebei Medical University Fourth Hospital
  • LanZhou University
  • Liaoning Cancer Hospital & Institute
  • Peking University Cancer Hospital & Institute
  • Shandong Provincial Hospital
  • Shanghai Zhongshan Hospital
  • Sun Yat-Sen University Cancer Center
  • The First Affiliated Hospital of Air Force Medicial University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital with Nanjing Medical University
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Xinjiang Medical University Cancer Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Apr 13, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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