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Brief Title: XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer
Official Title: XELOX III. Capecitabine (Xeloda) in Combination With Oxaliplatin (Eloxatin) as First-line Treatment of Patients With Advanced or Metastatic Colorectal Cancer. A Randomized Phase II Study
Study ID: NCT00212615
Brief Summary: 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
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Per Pfeiffer, MD
Affiliation: Department of Oncology, Odense University Hospital
Role: PRINCIPAL_INVESTIGATOR