Gastric CancerNCT02272894
A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer
An observational study of Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers. 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?
- Dissection of the Superior Mesenteric Vein Lymph Node
- Type of treatment
- Surgery or procedure
- How many people
- 510 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Dec 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Distal Advanced Gastric Cancer
Who may be able to join
- Curative D2 or D2+ operation had been performed;
- Physical condition and organ function allows to tolerable abdominal surgery;
- Willing and able to comply with the program during the study period;
- Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed;
- With more than a 6-month life expectancy;
- No other serious concomitant diseases;
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- No adjuvant chemotherapy before recurrence;
- Karnofsky performance status scale ≥ 60;
- All patients accept 6 cycles XELOX chemotherapy regimen
Who cannot join
- Pregnancy or breast feeding;
- Women of childbearing age do not take contraceptive measures;
- Organ transplantation patients need immunosuppressive therapy;
- Five years after the trial begin,other malignant tumor occur;
- While using other experimental drug or other clinical trials are being;
- Can not take oral medications;
- Mentally disordered;
- Severe recurrent infections were not controlled or with other serious concomitant diseases;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Liang Han, Master, 086-022-23340123 ext. 1061, tjlianghan@126.com
About this study
Official title: Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer
This trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.
Read the detailed description
Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Dissection of the Superior Mesenteric Vein Lymph Node
- Keywords
- Gastric Cancer, D2 Lymphadenectomy, Superior Mesenteric Vein Lymph Node
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissection of the Superior Mesenteric Vein Lymph NodeProcedure or surgery
14v lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| Group A | D2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node Receives: Procedure: Dissection of the Superior Mesenteric Vein Lymph Node | |
| Group B | D2 Radical Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.
Measured: 3 years
Secondary outcomes (1)
disease free survival
Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 510 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanxi Province Cancer Hospital, Peking University Cancer Hospital & Institute, Qingdao University, Fudan University, Sun Yat-sen University, Harbin Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Dalian Medical University, Qinghai University, Second Hospital of Jilin University, The First Affiliated Hospital of Zhengzhou University, Wulumuqi General Hospital of Lanzhou Military Command, Shandong Provincial Hospital, Nanjing PLA General Hospital
- Responsible party
- Sponsor
- Investigators
- Han Liang, Master, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272894
- Sponsor's protocol ID
- E201419A
- Status last verified
- Jul 2014
- First submitted
- 15 Sep 2014
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang QC, Zhou HK, Yue C, Wang WD, Gao RQ, Mo ZC, Ji PP, Wei JP, Yang XS, Yu PF, Li XH, Ji G. [The correlation between No. 6 and No. 14v lymph node metastasis and the value of dissecting these lymph nodes in radical gastrectomy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Jan 25;26(1):38-43. doi: 10.3760/cma.j.cn441530-20221123-00491. Chinese.
PubMed 36649998
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Mesenteric Vein (14V) Lymphadenectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT02272894
- Acronym / sponsor ID
- E201419A
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, D2 Lymphadenectomy, Superior Mesenteric Vein Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 510 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanxi Province Cancer Hospital, Peking University Cancer Hospital & Institute, Qingdao University, Fudan University, Sun Yat-sen University, Harbin Medical University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Dalian Medical University, Qinghai University, Second Hospital of Jilin University, The First Affiliated Hospital of Zhengzhou University, Wulumuqi General Hospital of Lanzhou Military Command, Shandong Provincial Hospital, Nanjing PLA General Hospital
- Study start
- Jul 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 Oct 2014 (estimated)
- 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 trial is going to evaluate the advantage of D2 radical gastrectomy plus 14v lymph node dissection in 3-year survival rates of advanced gastric cancers.
Detailed description
Radical surgery is still the only possible way to cure gastric cancer. In Japan, South Korea and other countries, due to the popularity of screening and Improved surgical procedures, there has been great improvement in overall survival. Standard D2 Gastrectomy has been the standard operation for advanced gastric cancer. However, there is no unanimous consensus whether Standard D2 Gastrectomy plus 14v lymph node dissection is needed.Till now, it is difficult to stage the 14V lymph node as regional lymph nodes metastasis or distant metastasis. And it is urgent to explore the necessity of 14v lymph node dissection in advanced gastric cancer.So a prospective randomized controlled study will to carry out to evaluate the effects of D2 radical gastrectomy plus 14v lymph node dissection compared with D2 radical gastrectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Dissection of the Superior Mesenteric Vein Lymph NodeD2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node |
| Group B | – | –D2 Radical Gastrectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Distal Advanced Gastric Cancer
Key inclusion criteria (9 listed)
- Curative D2 or D2+ operation had been performed;
- Physical condition and organ function allows to tolerable abdominal surgery;
- Willing and able to comply with the program during the study period;
- Aged 18 to 70 years, preoperative gastric cancer patients with pathologically confirmed;
- With more than a 6-month life expectancy;
Key exclusion criteria (8 listed)
- Pregnancy or breast feeding;
- Women of childbearing age do not take contraceptive measures;
- Organ transplantation patients need immunosuppressive therapy;
- Five years after the trial begin,other malignant tumor occur;
- While using other experimental drug or other clinical trials are being;
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 |
|---|---|---|
| Dissection of the Superior Mesenteric Vein Lymph Node14v lymph node dissection | Procedure or surgery | Group A |
Primary outcome
overall survival
Time frame: 3 years
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons.
1 secondary outcome
disease free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
- Derived from this study: PubMed 36649998Yang QC, Zhou HK, Yue C, Wang WD, Gao RQ, Mo ZC, Ji PP, Wei JP, Yang XS, Yu PF, Li XH, Ji G. [The correlation between No. 6 and No. 14v lymph node metastasis and the value of dissecting these lymph nodes in radical gastrectomy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2023 Jan 25;26(1):38-43. doi: 10.3760/cma.j.cn441530-20221123-00491. Chinese.
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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. This study is not recruiting at the moment.
Han Liang, Master principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Liang, Master (086-022-23340123 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?
overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02272894, which also lists 1 linked publication.
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 9 Dec 2015.