NCT02272894

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 9, 2015

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

September 15, 2014

Last Update Submit

December 8, 2015

Conditions

Gastric Cancer

Keywords

Gastric CancerD2 LymphadenectomySuperior Mesenteric Vein Lymph Node

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • disease free survival

    3 years

Study Arms (2)

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

Dissection of the Superior Mesenteric Vein Lymph NodePROCEDURE

14v lymph node dissection

Group A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Distal Advanced Gastric Cancer

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36649998DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Han Liang, Master

    Tianjin Medical University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Liang, Master

CONTACT

086-022-23340123tjlianghan@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

October 23, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 9, 2015

Record last verified: 2014-07

Locations

CN(1)