A Trial to Evaluate the Superior Mesenteric Vein (14V) Ly... | NCT02272894

Studies
A Trial to Evaluate the Superior Mesenteric Vein (14V) Lymphadenectomy for Distal Advanced Gastric Cancer

NCT02272894

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Dec 9, 2015Estimated

Enrollment

510Estimated

Phase

Not provided

Conditions

Gastric Cancer

Interventions

Dissection of the Superior Mesenteric Vein Lymph Node

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Nov 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 15, 2014

First Submission Date that Met QC Criteria

Oct 21, 2014

First Posted Date

Oct 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Tianjin Medical University Cancer Institute and HospitalOTHER

Collaborators

Name	Class
The First Affiliated Hospital with Nanjing Medical University	OTHER
Shanxi Province Cancer Hospital	OTHER
Peking University Cancer Hospital & Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

510Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		D2 Radical Gastrectomy Adding Dissection of the Superior Mesenteric Vein Lymph Node	Procedure: Dissection of the Superior Mesenteric Vein Lymph Node
Group B		D2 Radical Gastrectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dissection of the Superior Mesenteric Vein Lymph Node	Procedure	14v lymph node dissection	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 years

Secondary Outcomes

Measure	Description	Time Frame
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.	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
No adjuvant chemotherapy before recurrence;
Karnofsky performance status scale ≥ 60;
All patients accept 6 cycles XELOX chemotherapy regimen

Exclusion Criteria:

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;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Distal Advanced Gastric Cancer

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Han Liang, Master	Contact	086-022-23340123	1061	tjlianghan@126.com

Overall Officials

Name	Affiliation	Role
Han Liang, Master	Tianjin Medical University Cancer Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital	Recruiting	Tianjin	Tianjin Municipality	300060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36649998	Derived	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.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms