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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
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This study will investigate
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy only | Other | Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene |
|
| Chemotherapy + biological treatment | Other | Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | 130 mg/m2 intravenously on day 1 of a 3-weekly cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation. | Within 1 week after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | Up to 2 years. | |
| Overall survival | Up to 2 years. |
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Inclusion Criteria:
Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan
Analysis of KRAS, BRAF, PIK3CA
Age ≥18 år
Performance status ≤ 2
Hematology
Biochemistry
Consent to translational research
Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment.
Written and orally informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, DMSc | Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Herlev Hospital | Herlev | DK-2730 | Denmark | |||
| Dept. of Oncology, Hilleroed Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26183044 | Derived | Dam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103. |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Capecitabine |
| Drug |
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle |
|
| Oxaliplatin | Drug | 130 mg/m2 intravenously on day 1 of a 3-weekly cycle |
|
| Capecitabine | Drug | 2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle |
|
| Panitumumab | Biological | 9 mg/kg intravenously on day 1 of a 3-weekly cycle |
|
| Hilleroed |
| 3400 |
| Denmark |
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| 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 |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |