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Primary endpoint of the study is to prove the superiority of an adjuvant therapy with oxaliplatin/ capecitabine until the first occurrence of appearance of a tumour. Occurrences in the meaning of this study are the appearance of a relapse of the tumour, of metastases, of a second tumour or death of any reason.
Prospective, randomized, multi-centre, open phase III study with two parallel groups of patients according to the eligibility criteria. The times in both hierarchical classified endpoints will be measured as times from randomization.
Patients with macroscopic complete resection of colorectal liver metastases will be randomized in:
Arm A: post-operative adjuvant therapy with Capecitabine/ Oxaliplatin over 6 months and follow-up
or
Arm B: follow-up
Randomization: stratification after Scores of Fong et al:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | |||
| Oxaliplatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcomes: | ||
| Disease free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes:overall survival,acute- and longtime toxicity of chemotherapy, molecular predictive markers for the risk of relapse and toxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolf O. Bechstein, Prof. Dr. | Arbeitsgruppe Lebermetastasen und Tumoren | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik | Dresden | Saxony | 011307 | Germany | ||
| Universitaetsklinikum Essen, Klinik für Allgemein- und Transplantationschirurgie OPZ II |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Essen |
| 45122 |
| Germany |
| Klinik für Allgemein- und Gefäßchirurgie , J. W. Goethe Universität | Frankfurt am Main | 60590 | Germany |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |