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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Gastric cancer patients receiving Herceptin in routine clinical practice
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie | Frankfurt | 60488 | Germany |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Documentation of backbone chemotherapy treatment and concomitant medication | 12 months |
| Quality of Life questionnaire | 12 months |
| Surveillance of pain intensity and analgesic consumption | 12 months |
| Surveillance of weight change | 12 months |
| Safety (incidence of adverse events) | 12 months |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |