Clinical trial · Interventional
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)
NCT04843215CI-TRIAL-00051701recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Type of omentectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group/D2 radical gastrectomy with partial omentectomy
- description
- Partial omentectomy with preservation of the greater omentum at \>3 cm from the gastroepiploic arcade.
- interventionNames
- Procedure: Type of omentectomy
- type
- NO_INTERVENTION
- label
- Control group/D2 radical gastrectomy with total omentectom
- description
- Control group with total omentectomy
Primary outcomes (1)
- measure
- Disease Free Survival(DFS)
- timeFrame
- 3 years
- description
- Disease Free Survivalof the Participants
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Had been treated with Radical resection (D2, R0) of gastric cancer (Lymph node≥16); 2. Physical condition and organ function allows to tolerable abdominal surgery; 3. Willing and able to comply with the program during the study period; 4. Written informed consent provided; 5. ≥ 18 and ≤ 70 years of age; preoperative gastric cancer patients with pathologically confirmed; 6. With more than a 6-month life expectancy; 7. No other serious concomitant diseases; Sufficient organ functions; 8. No previous history of chemotherapy or radiotherapy; 9. All patients accept 8 cycles XELOX chemotherapy regimen; 10. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.