NCT02192983

Brief Summary

This study is designed to assess what is the better neoadjuvant chemotherapy regimen for patients with initially unresectable locally advanced gastric cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2008

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 3, 2015

Status Verified

November 1, 2015

Enrollment Period

6.5 years

First QC Date

July 15, 2014

Last Update Submit

November 30, 2015

Conditions

Locally Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

    6 months after diagnosis

Study Arms (1)

chemotherapy regimen

those with XELOX regimen and those with EOX regimen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

242

You may qualify if:

  • more than 2 regional bulky lymph nodes macroscopic tumor type is either the Borrmann type 4 or large type 3 tumor invades adjacent structures (T4b)

You may not qualify if:

  • peritoneal metastasis confirmed by CT scan lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Zhongshan Ethics Committee

Shanghai, Shanghai Municipality, China

Location

Study Officials

  • tianshu liu

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman of the department of oncology

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

November 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

December 3, 2015

Record last verified: 2015-11

Locations

CN(1)