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Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)


N/A
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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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

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