Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Adenocarcinoma of the Stomach or Gastroesophageal Junction. A Non-interventional Study

University of Leipzig1 site in 1 country549 target enrollmentMarch 2014

ConditionsEsophageal Neoplasms Stomach Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophageal Neoplasms
Sponsor: University of Leipzig
Enrollment: 549
Locations: 1
Primary Endpoint: Percentage of Participants With Objective Response
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to identify biomarkers predicting response or resistance factors of a targeted therapy with trastuzumab in advanced gastric cancer.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

January 31, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Leipzig

Responsible Party

Principal Investigator

Florian Lordick, MD

Director University Cancer Center Leipzig

University of Leipzig

Eligibility Criteria

Inclusion Criteria

•histologically proven adenocarcinoma of the stomach or gastroesophageal junction
•patient receives chemotherapy
•signed informed consent
•Age \> 18 years

Exclusion Criteria

•Patient can not understand meaning and purpose of the study
•patient already received a chemotherapy treatment for advanced disease.

Outcomes

Primary Outcomes

Percentage of Participants With Objective Response

Time Frame: 12 months

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimension of the target lesion