Gastric CancerNCT04843215
A Phase III Study Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer
A study testing Type of omentectomy in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Type of omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Liang Han, 086-022-23340123 ext. 1061, tjlianghan@126.com
About this study
Official title: A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Read the detailed 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.
- Conditions
- Gastric Cancer
- Being tested
- Type of omentectomy
- Keywords
- Gastric Cancer, Prognosis, Omentectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of omentectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group/D2 radical gastrectomy with partial omentectomy | Experimental | Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade. Receives: Procedure: Type of omentectomy |
| Control group/D2 radical gastrectomy with total omentectom | No intervention | Control group with total omentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival(DFS)
Disease Free Survivalof the Participants
Measured: 3 years
Secondary outcomes (1)
Overall Survival(OS)
Overall Survival of the Participants
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fujian Cancer Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Guangxi Medical University, Harbin Medical University, Hebei Medical University Fourth Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital with Nanjing Medical University, Changzhi People's Hospital, The First Affiliated Hospital of Air Force Medical University, First Affiliated Hospital of Kunming Medical University, LanZhou University, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Nanchang University, Shandong Provincial Hospital, West China Hospital, Xinjiang Medical University Cancer Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Sun Yat-Sen University Cancer Center, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843215
- Sponsor's protocol ID
- E20210171
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Prospective, Randomized, Controlled Clinical Trial Comparing Total and Partial Omentectomy for Patients With Advanced Gastric Cancer (TOP-GC)
- ClinicalTrials.gov ID
- NCT04843215
- Acronym / sponsor ID
- E20210171
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Prognosis, Omentectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, Shanghai Zhongshan Hospital, Fujian Cancer Hospital, Fujian Medical University Union Hospital, First Affiliated Hospital of Guangxi Medical University, Harbin Medical University, Hebei Medical University Fourth Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital with Nanjing Medical University, Changzhi People's Hospital, The First Affiliated Hospital of Air Force Medical University, First Affiliated Hospital of Kunming Medical University, LanZhou University, Liaoning Cancer Hospital & Institute, The First Affiliated Hospital of Nanchang University, Shandong Provincial Hospital, West China Hospital, Xinjiang Medical University Cancer Hospital, Zhejiang Cancer Hospital, Chinese PLA General Hospital, Sun Yat-Sen University Cancer Center, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, multicenter, prospective, randomized, controlled clinical trial to evaluate the impact of omentectomy for advanced gastric cancer on patient survival.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group/D2 radical gastrectomy with partial omentectomy | Experimental | Procedure: Type of omentectomyPartial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade. |
| Control group/D2 radical gastrectomy with total omentectom | No intervention | –Control group with total omentectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of omentectomyExperimental 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. | Procedure or surgery | Experimental group/D2 radical gastrectomy with partial omentectomy |
Primary outcome
Disease Free Survival(DFS)
Time frame: 3 years
Disease Free Survivalof the Participants
1 secondary outcome
Overall Survival(OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of omentectomy in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han Liang, Master (+86 022 233401 23 ext. 1061, tjlianghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival(DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.