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

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01220934
First received: September 28, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of the testing process for HER2-positive tumors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Documentation of backbone chemotherapy treatment and concomitant medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of Life questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Surveillance of pain intensity and analgesic consumption [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Surveillance of weight change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: April 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Gastric cancer patients receiving Herceptin in routine clinical practice

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220934

Contacts
Contact: Reference Study ID Number: ML22834 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Germany
Recruiting
Frankfurt, Germany, 60488
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01220934     History of Changes
Other Study ID Numbers: ML22834
Study First Received: September 28, 2010
Last Updated: May 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013