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

Hoffmann-La Roche63 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

CapecitabineDRUG

Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m\^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Unnamed facility

Blagoevgrad, Bulgaria

Unnamed facility

Rousse, Bulgaria

Unnamed facility

Shumen, Bulgaria

Unnamed facility

Sofia, Bulgaria

Unnamed facility

Sofia, Bulgaria

Outcomes

Primary Outcomes

Incidence of adverse events (AEs)

Time frame: Up to approximately 6 months

Incidence of treatment discontinuation due to AEs

Time frame: Up to approximately 6 months

Secondary Outcomes

Incidence of toxocity-related dose reductions

Time frame: Up to approximately 6 months

Data from ClinicalTrials.gov

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