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Completed

NCT Number: NCT01220934

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie

Frankfurt, 60488, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 12 months

  2. Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 12 months

  3. Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 12 months

Secondary outcomes

  1. Documentation of the testing process for HER2-positive tumors

    Time frame: 12 months

  2. Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice

    Time frame: 12 months

  3. Documentation of backbone chemotherapy treatment and concomitant medication

    Time frame: 12 months

  4. Quality of Life questionnaire

    Time frame: 12 months

  5. Surveillance of pain intensity and analgesic consumption

    Time frame: 12 months

  6. Surveillance of weight change

    Time frame: 12 months

  7. Safety (incidence of adverse events)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2010
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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