A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer

Phase 4

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine

• 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

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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

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

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