A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer
A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Han Liang, Master
- Phone Number: 1061 +86 022 233401 23
- Email: tjlianghan@126.com
Study Contact Backup
- Name: Bik Ke, Doctor
- Phone Number: 1061 +86 022 23340123
- Email: binke@tmu.edu.cn
Study Locations
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Recruiting
- Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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;
12. 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.
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; 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental group/D2 radical gastrectomy with partial omentectomy
Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.
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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.
|
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NO_INTERVENTION: Control group/D2 radical gastrectomy with total omentectom
Control group with total omentectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease Free Survival(DFS)
Time Frame: 3 years
|
Disease Free Survivalof the Participants
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival(OS)
Time Frame: 5 years
|
Overall Survival of the Participants
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The volume of intraoperative blood loss
Time Frame: 1 week
|
The volume of intraoperative blood loss (IBL) was defined as the total from suction and the weight of gauze sponges at the conclusion of the operation.
The Blood loss volume is recorded in milliliters.
|
1 week
|
|
Postoperative morbidity
Time Frame: 1 month
|
Postoperative morbidity was defined as the incidence rate of the postoperative complication.
The postoperative morbidity were examined within 30 days after surgery.
Postoperative morbidity was graded with use of the modified Clavien-Dindo classification of surgical complications.
|
1 month
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E20210171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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