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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    950
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 16 May 2021

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.

Description

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.

Details
Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Type of omentectomy
Clinical Study IdentifierNCT04843215
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node16)
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
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note