Phase 4
Completed N=228
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
Source: ClinicalTrials.gov NCT00502671 ↗Enrolled (actual)
228
Serious AEs
6.1%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE — 56.1; 6.1; 0.4 percentage of participants
Summary
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE |
56.1; 6.1; 0.4 | — |
| SECONDARY Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE |
8.3; 10.1 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of <=1.
Exclusion Criteria
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
Data sourced from ClinicalTrials.gov (NCT00502671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.