A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
- Registration Number
- NCT02581423
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the safety and tolerability of capecitabine (Xeloda) in participants who have undergone surgery for colon cancer. Oral Xeloda will be administered twice daily in 3-week cycles for a total of up to 8 cycles. The anticipated time on study treatment is 24 weeks, and the target sample size is 70 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Adults at least 18 years of age
- Curative surgery for Stage III colon cancer, performed 4 to 8 weeks before study entry
Read More
Exclusion Criteria
- Macroscopic or microscopic residual tumor
- Evidence of metastatic disease including tumor cells in ascites
- Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy for colon cancer
- Active cardiovascular disease
- Other malignancy within the last 5 years, other than curatively treated basal cell cancer of the skin or in situ cancer of the cervix
- Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Capecitabine Capecitabine Participants will receive capecitabine for up to approximately 6 months.
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to approximately 6 months Incidence of treatment discontinuation due to AEs Up to approximately 6 months
- Secondary Outcome Measures
Name Time Method Incidence of toxocity-related dose reductions Up to approximately 6 months