Esophageal Neoplasms, Stomach Neoplasms
Conditions
Keywords
non-interventional, advanced gastric cancer, Trastuzumab, HER2
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.
Interventions
OTHERnon-interventional
non-interventional
Sponsors
German Federal Ministry of Education and Research
University of Leipzig
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed