Clinical trial · Interventional
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer
An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer
NCT02567331CI-TRIAL-00024586completedPhase 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 efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 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 oral capecitabine 1250 milligrams per square meter (mg/m\^2) twice daily for 14 days followed by 7 day rest period for 6 cycles.
- interventionNames
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- up to approximately 1.5 years
- measure
- Response rate, ie, percentage of participants with complete, partial, and overall response
- timeFrame
- up to approximately 1.5 years
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients greater than or equal to (\>=) 18 years of age * Metastatic colorectal cancer Exclusion Criteria: * Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease * Central nervous system and bone metastases * Moderate or severe renal impairment * Clinically significant cardiac disease * Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication * Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix
References
Publications (0)
Data not yet available
No reference posted for this study.