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

NCT04108494 | Unknown DMC

• 1 other identifier: E2019054
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Omentectomy; Prognosis

Outcome Measures

Primary Outcomes (1)

• 3 years relapse-free survival

  Relapse-free survival l (RFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.

  3 years

Secondary Outcomes (1)

• 5 years overall survival

  5 years

Other Outcomes (4)

• The volume of intraoperative blood loss

  1 week

• The length of the operation

  1 week

• Postoperative hospital stay

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

D2 radical gastrectomy with partial omentectomy

Procedure: Type of omentectomy

Control group

NO INTERVENTION

D2 radical gastrectomy with total omentectom

Interventions

Type of omentectomy PROCEDURE

Partial omentectomy with preservation of the greater omentum at \>3 cm from the gastroepiploic arcade.Control group with total omentectomy.

Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: T2-4aN0-+M0;
• Macroscopic types :Borrmann I-III;
• Not greater curvature tumor;
• No previous surgery for any abdominal disease, except an appendectomy for appendicitis, a laparoscopic cholecystectomy for gallbladder stones; No previous history of peritonitis, pancreatitis;
• Karnofsky performance status (KPS)\>60; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1.

You may not qualify if:

• Pregnancy or breast feeding;
• 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;
• Organ transplantation patients need immunosuppressive therapy;
• Severe recurrent infections were not controlled or with other serious concomitant diseases;
• Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years;
• Psychiatric disease which require treatment;
• Have the history of organ transplantation;
• Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
• Advanced gastric cancer with omentum invasion
• Patients can't treated with XELOX after surgery;
• Macroscopic types : Borrmann IV;
• Tumor invasion of adjacent organ (T4b) or with distant metastasis（M1）;
• Tumor invasion the greater curvature invasion.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Han Liang, Master

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Han Liang, Master

CONTACT

+86 022 23340123; tjlianghan@126.com

Bin Ke, Doctor

CONTACT

+86 13622036809; binke@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2019
• First Posted: September 30, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

CN (1)