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)
1 other identifier
observational
443
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 16, 2010
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
October 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 20, 2018
June 1, 2018
6.1 years
September 28, 2010
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
Documentation of the testing process for HER2-positive tumors
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
Quality of Life questionnaire
12 months
Surveillance of pain intensity and analgesic consumption
12 months
- +2 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Gastric cancer patients receiving Herceptin in routine clinical practice
You may qualify if:
- 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
You may not qualify if:
- Unwilling or unable to sign informed consent form
- Any contraindications, interactions and incompatibilities to Herceptin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, 60488, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2010
First Posted
October 14, 2010
Study Start
April 16, 2010
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 20, 2018
Record last verified: 2018-06