Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT04843215

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

Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2021-05-10

950

Participants Needed

1

Research Sites

312 weeks

Total Duration

On this page

Sponsors

T

Tianjin Medical University Cancer Institute and Hospital

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Treated with radical D2 R0 resection of gastric cancer with at least 16 lymph nodes removed
  • Physically able to tolerate abdominal surgery
  • Willing and able to comply with study procedures
  • Provided written informed consent
  • Between 18 and 70 years old with pathologically confirmed preoperative gastric cancer
  • Life expectancy of more than 6 months
  • No other serious diseases and sufficient organ function
  • No prior chemotherapy or radiotherapy
  • Accept 8 cycles of XELOX chemotherapy
  • Clinical stage T3-4aN0-+M0
  • Macroscopic Borrmann types I-III
  • Tumor not on the greater curvature; undergoing distal or total gastrectomy
  • No previous abdominal surgery except appendectomy or laparoscopic cholecystectomy; no history of peritonitis or pancreatitis
  • Karnofsky performance status greater than 60; ECOG performance status 0-1
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Serious liver, kidney, respiratory diseases, uncontrolled diabetes, hypertension, or heart disease with symptoms
  • Organ transplant patients requiring immunosuppressive therapy
  • Severe uncontrolled infections or serious concomitant diseases
  • Other primary malignant tumors within 5 years except certain skin and cervical cancers
  • Psychiatric diseases requiring treatment
  • History of organ transplantation
  • Participation in other clinical research within 6 months before or during this study
  • Advanced gastric cancer with omentum invasion
  • Unable to receive XELOX chemotherapy after surgery
  • Macroscopic Borrmann type IV
  • Tumor invading adjacent organs (T4b) or with distant metastasis
  • Tumor invading the greater curvature of the stomach

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China, 300060

Actively Recruiting

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Research Team

H

Han Liang, Master

CONTACT

B

Bik Ke, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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