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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01220934
First received: September 28, 2010
Last updated: March 21, 2017
Last verified: March 2017
  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:


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 ]
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ]
  • Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 12 months ]

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

Enrollment: 443
Actual Study Start Date: April 16, 2010
Study Completion Date: June 1, 2016
Primary Completion Date: June 1, 2016 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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: March 21, 2017

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

ClinicalTrials.gov processed this record on June 28, 2017