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

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT01220934
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-16
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 443

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

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Exclusion Criteria

• Unwilling or unable to sign informed consent form
• Any contraindications, interactions and incompatibilities to Herceptin

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months
Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months
Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie; 🇩🇪 Frankfurt, Germany