Trial Information
Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal
junction (GEJ) with locally advanced and/or metastatic disease
- HER2-positive tumor
- Patients who are eligible for treatment with Herceptin according to the judgment of
the physician
Exclusion Criteria:
- Unwilling or unable to sign informed consent form
- Any contraindications, interactions and incompatibilities to Herceptin
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
ML22834
NCT ID:
NCT01220934
Start Date:
April 2010
Completion Date:
January 2014
Related Keywords:
- Gastric Cancer
- Stomach Neoplasms