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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Orally on days 1-14: 2000 mg/m2/day q3w
Intravenously on day 1: 130 mg/m2 q3w
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Hilleroed Hospital
Hillerød, Denmark
Two-year disease free survival
Time frame: 2 years after completed study treatment
Rate of patients fulfilling the criteria for adjuvant chemotherapy
Time frame: 6, 12, 18, and 24 months after completed study treatment
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Roskilde Hospital
Roskilde, Denmark
Sygehus Sønderjylland
Sønderborg, Denmark
Vejle Hospital
Vejle, Denmark
Haukeland University Hospital
Bergen, Norway
Sahlgrenska University Hospital
Gothenburg, Sweden