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The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.
Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A, Conventional treatment | Other | Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated. |
|
| B, Neoadjuvant chemotherapy | Other | 3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Orally on days 1-14: 2000 mg/m2/day q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Two-year disease free survival | 2 years after completed study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients fulfilling the criteria for adjuvant chemotherapy | 6, 12, 18, and 24 months after completed study treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Jakobsen, DMSc | Vejle Hospital, Vejle, Denmark | Study Chair |
| Henrik Jensen, MD, PhD | Vejle Hospital, Vejle, Denmark | Principal Investigator |
| Olav Dahl, MD | Haukeland University Hospital, Bergen, Norway | Principal Investigator |
| Göran Carlsson, MD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Rigshospitalet |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41779406 | Derived | Jensen LH, Kjaer M, Diness LV, Hollander NH, Rahr HB, Pfeffer F, Larsen FO, Lindebjerg J, Rafaelsen SR, Hansen TF, Timm S, Loes IM, Gogenur I, Zitnjak D, Andersen F, Petersen LN, Lindskog EB, Poulsen LO, Dahl O. Neoadjuvant Chemotherapy vs Upfront Surgery in Patients With Locally Advanced Colon Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 May 1;161(5):450-458. doi: 10.1001/jamasurg.2026.0085. |
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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 |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Oxaliplatin | Drug | Intravenously on day 1: 130 mg/m2 q3w |
|
| Copenhagen |
| Denmark |
| Herlev Hospital | Herlev | Denmark |
| Hilleroed Hospital | Hillerød | Denmark |
| Roskilde Hospital | Roskilde | Denmark |
| Sygehus Sønderjylland | Sønderborg | Denmark |
| Vejle Hospital | Vejle | Denmark |
| Haukeland University Hospital | Bergen | Norway |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal 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 |