NCT04843215Recruiting
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)
Source: ClinicalTrials.gov · Last updated 10 May 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 950 (estimated)
- First submitted
- 11 Apr 2021
- Start date
- 1 Jan 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04843215
What you commit to
- Study type: Interventional
- Planned participants: 950
- From 1 Jan 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.