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| ID | Type | Description | Link |
|---|---|---|---|
| KFE 03.17 |
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XELOX (Capecitabine and Oxaliplatin) is an effective and convenient regimen for patients with metastatic colorectal cancer. Chronomodulated therapy may reduce toxicity. Patients will be randomized to standard XELOX (Capecitabine 1000 mg/m² in the morning and 1000 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes) or chronomodulated XELOX (Capecitabine 400 mg/m² in the morning and 1600 mg/m² in the evening days 1-14 and short term Oxaliplatin 130 mg/m² day 1 in 30 minutes).
Bloodsamples will be collected and frozen and later examined for potential predictive factors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Standard XELOX |
|
| B | Active Comparator | Chronomodulated XELOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin (Eloxatin) | Drug |
| ||
| Capecitabine (Xeloda) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event) |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination: before treatment (each 3 weeks) | ||
| Performance status: before treatment (each 3 weeks) | ||
| Haematology: before treatment (each 3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Pfeiffer, MD | Department of Oncology, Odense University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Esbjerg Hospital | Esbjerg | 6700 | Denmark | |||
| Department of Oncology, Herlev University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14968944 | Background | Pfeiffer P, Hahn P, Jensen HA. Short-time infusion of oxaliplatin (Eloxatin) in combination with capecitabine (Xeloda) in patients with advanced colorectal cancer. Acta Oncol. 2003;42(8):832-6. doi: 10.1080/02841860310015894. | |
| 23864097 | Derived | Boisen MK, Johansen JS, Dehlendorff C, Larsen JS, Osterlind K, Hansen J, Nielsen SE, Pfeiffer P, Tarpgaard LS, Hollander NH, Keldsen N, Hansen TF, Jensen BB, Jensen BV. Primary tumor location and bevacizumab effectiveness in patients with metastatic colorectal cancer. Ann Oncol. 2013 Oct;24(10):2554-2559. doi: 10.1093/annonc/mdt253. Epub 2013 Jul 17. |
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|
| Tumor biology: after 1st treatment, every 9th weeks herafter |
| Biochemistry: after every 3rd treatment (each 9th weeks) |
| Tumor assesment: after every 3rd treatment (each 9th weeks) |
| Herlev |
| 2730 |
| Denmark |
| Department of Oncology, Herning Hospital | Herning | 7400 | Denmark |
| Department of Oncology, Hillerød Hospital | Hillerød | 3400 | Denmark |
| Department of Oncology, Næstved Hospital | Næstved | 4700 | Denmark |
| Department of Oncology, Roskilde Hospital | Roskilde | 4000 | Denmark |
| Department of Oncology, Radiumhemmet | Stockholm | 100 26 | Sweden |
| Department of Oncology, Uppsala University Hospital | Uppsala | 751 85 | Sweden |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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