Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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