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Xeloda vs 5-FU/LV in Adjuvant Colon Cancer (X-ACT)
NCT00009737Phase 3
Key facts
- Status
- Completed
- Start
- Nov 1998
- Primary completion
- Apr 2004
- Countries
- 14
- Sponsor
- Roche
- Modality
- DNA Intercalators/Alkylators, Irreversible Covalent Inhibitors, RNA-Targeting Small Molecules
- Drugs
- capecitabine
- Conditions
- colon cancer
01
Overview
Phase 3, randomised, open-label trial of capecitabine in colon cancer (2 arms), sponsored by Roche. Primary endpoint: Disease-free Survival at 3 years. Started Nov 1998; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Capecitabine
Oral capecitabine monotherapy
5-FU + Leucovorin
IV 5-Fluorouracil + Leucovorin (Mayo Clinic Regimen)
03
Who it enrols
Adult patients (18-75 years) with histologically confirmed Dukes C (Stage III) colon cancer who have undergone potentially curative resection within 8 weeks prior to study initiation. Patients with previous chemotherapy are excluded.
04
Endpoints
Primary
Disease-free Survival
Secondary
Relapse-Free Survival
Overall Survival
Mean Change From Baseline in Global Health Status
Adverse Events and Serious Adverse Events
05
Results
Primary endpoints met
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