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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220934
• Other study ID #: ML22834
• Status: Completed
• Start date: April 16, 2010
• Est. completion date: June 1, 2016

Study information

• Verified date: June 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Germany	Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)		12 months
Primary	Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)		12 months
Primary	Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)		12 months
Secondary	Documentation of the testing process for HER2-positive tumors		12 months
Secondary	Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice		12 months
Secondary	Documentation of backbone chemotherapy treatment and concomitant medication		12 months
Secondary	Quality of Life questionnaire		12 months
Secondary	Surveillance of pain intensity and analgesic consumption		12 months
Secondary	Surveillance of weight change		12 months
Secondary	Safety (incidence of adverse events)		12 months