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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Department of Oncology, Esbjerg Hospital
Esbjerg, Denmark
Department of Oncology, Herlev University Hospital
Herlev, Denmark
Department of Oncology, Herning Hospital
Herning, Denmark
Department of Oncology, Hillerød Hospital
Hillerød, Denmark
Department of Oncology, Næstved Hospital
Næstved, Denmark
Department of Oncology, Roskilde Hospital
Roskilde, Denmark
Department of Oncology, Radiumhemmet
Stockholm, Sweden
Department of Oncology, Uppsala University Hospital
Uppsala, Sweden
Toxicity: before treatment (each 3 weeks) and by SAE (Serious Adverse Event)
Physical examination: before treatment (each 3 weeks)
Performance status: before treatment (each 3 weeks)
Haematology: before treatment (each 3 weeks)
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)
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