Identification of Biomarkers for Prediction of Response or Resistance Against Target Therapy in Gastric Cancer

Completed

• Conditions: Stomach Neoplasms; Esophageal Neoplasms

• Registration Number: NCT02305043
• Lead Sponsor: University of Leipzig

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-11-17
• Study First Submitted QC: 2014-11-27
• Study First Posted: 2014-12-02
• Primary Completion: 2018-01
• Study Completion: 2018-01-31
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

• histologically proven adenocarcinoma of the stomach or gastroesophageal junction

  • stage IV
  • 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Objective Response	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

Secondary Outcome Measures

Name	Time	Method
time-to-progression	up to 24 months	The period from study entry until disease progression, death, or date of last contact.
overall survival	up to 24 months	OS is the duration from enrollment to death.

Trial Locations

Locations (1)

University Cancer Center Leipzig; 🇩🇪 Leipzig, Germany