NCT00212615

XELOX III. Xeloda in Combination With Eloxatin for Patients With Advanced or Metastatic Colorectal Cancer

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• C04.588.274.476.411.307

Interventions

Type	Name	Description
DRUG	Oxaliplatin (Eloxatin)
DRUG	Capecitabine (Xeloda)

Timeline

• Start date: 2004-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2005-09-21
• Last updated: 2020-11-06

Locations

8 sites across 2 countries: Denmark, Sweden