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The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adecatumumab alone |
|
| 2 | Experimental | FOLFOX 4 followed by Adecatumumab |
|
| 3 | Active Comparator | FOLFOX 4 alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adecatumumab | Drug | Adecatumumab,6-9mg/kg, every 14 days, 24 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival rate (DFS) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| time to relapse | 1 year | |
| Incidence of AEs | 1 year | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Neuhaus, Prof. Dr. | Charité Campus Virchow Klinikum, Berlin | Principal Investigator |
| Patrick Dufour, Pr. Dr. | Centre Paul Strauss, Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Paul Strauss | Strasbourg | 67065 | France | |||
| Zentralklinikum Augsburg |
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| Adecatumumab and FOLFOX | Drug | FOLFOX 4, every 14 days, 12 cycles followed by Adecatumumab, 6-9mg/kg, every 14 days, 12 cycles |
|
| FOLFOX 4 | Drug | FOLFOX 4, every 14 days, 12 cycles |
|
| 1 year |
| Augsburg |
| 86156 |
| Germany |
| Klinikum am Bruderwald, Sozialstiftung Bamberg | Bamberg | 96049 | Germany |
| Charité Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Klinikum der Heinrich-Heine Universität | Düsseldorf | 40489 | Germany |
| J.W. Goethe-Universität | Frankfurt | 60590 | Germany |
| Martin-Luther Universität | Halle | 06120 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Klinikum Magdeburg gGmbH | Magdeburg | 39130 | Germany |
| Klinikum der Johannes-Gutenberg Universität | Mainz | 55131 | Germany |
| Klinikum Mannheim GmbH Universitätsklinikum | Mannheim | 68167 | Germany |
| Universitätsklinikum der LMU Grosshadern | München | 81377 | Germany |
| Städtisches Klinikum Neuperlach | München | 81737 | Germany |
| Klinikum Oldenburg gGmbH | Oldenburg | 26133 | Germany |
| Klinikum der Universität Regensburg | Regensburg | 93053 | Germany |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C460839 | adecatumumab |
| C410216 | Folfox protocol |
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