NCT04843215

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
8mo left

Started Jan 2021

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jan 2021Dec 2026

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 10, 2021

Status Verified

April 1, 2021

Enrollment Period

3 years

First QC Date

April 11, 2021

Last Update Submit

May 5, 2021

Conditions

Gastric Cancer

Keywords

Gastric CancerPrognosisOmentectomy

Outcome Measures

Primary Outcomes (1)

  • Disease Free Survival(DFS)

    Disease Free Survivalof the Participants

    3 years

Secondary Outcomes (1)

  • Overall Survival(OS)

    5 years

Other Outcomes (2)

  • The volume of intraoperative blood loss

    1 week

  • Postoperative morbidity

    1 month

Study Arms (2)

Experimental group/D2 radical gastrectomy with partial omentectomy

EXPERIMENTAL

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

Procedure: Type of omentectomy

Control group/D2 radical gastrectomy with total omentectom

NO INTERVENTION

Control group with total omentectomy

Interventions

Type of omentectomyPROCEDURE

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.

Experimental group/D2 radical gastrectomy with partial omentectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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: 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Han Liang, Master

CONTACT

+86 022 233401 23tjlianghan@126.com

Bik Ke, Doctor

CONTACT

+86 022 23340123binke@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

April 11, 2021

First Posted

April 13, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

May 10, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)