Overview

This trial is active, not recruiting.

Condition gastric cancer
Sponsor Hoffmann-La Roche
Trial size 443 participants
Trial identifier NCT01220934, ML22834

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.