An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01220934

Enrollment

443

Registered

2010-10-14

Start date

2010-04-16

Completion date

2016-06-01

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Brief summary

This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months
Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months

Secondary

Measure	Time frame
Quality of Life questionnaire	12 months
Surveillance of pain intensity and analgesic consumption	12 months
Documentation of the testing process for HER2-positive tumors	12 months
Safety (incidence of adverse events)	12 months
Surveillance of weight change	12 months
Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice	12 months
Documentation of backbone chemotherapy treatment and concomitant medication	12 months

Countries

Germany

Outcome results