Clinical trial · Interventional
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine [Xeloda] | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: capecitabine [Xeloda]
Primary outcomes (1)
- measure
- Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
- timeFrame
- Up to 25 weeks (from Baseline to the end of safety follow-up)
- description
- The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available