Clinical trial · Interventional
A Study of Capecitabine (Xeloda) in the Adjuvant Treatment of Participants With Resected Colon Cancer
Phase IV Clinical Study of Safety and Tolerability of Oral Xeloda (Capecitabine) in Adjuvant Treatment of Resected Cancer of the Colon
NCT02581423CI-TRIAL-00024638completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 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.
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 | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- Participants will receive capecitabine for up to approximately 6 months.
- interventionNames
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- Up to approximately 6 months
- measure
- Incidence of treatment discontinuation due to AEs
- timeFrame
- Up to approximately 6 months
Secondary outcomes (1)
- measure
- Incidence of toxocity-related dose reductions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.