Clinical trial · Observational
An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)
Evaluation of Safety and Efficacy of Xeloda in Metastatic Colorectal Carcinoma
NCT01697462CI-TRIAL-00020661completedResults postedClinicalTrials.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 prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort
Primary outcomes (1)
- measure
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- Baseline up to end of study (up to 42 months)
- description
- An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs was exclusive of serious AEs.
Secondary outcomes (3)
- measure
- Percentage of Participants With Disease Progression
- timeFrame
- Baseline to progressive disease or death (up to 42 months)
- description
- Disease progression was defined as greater than 20 percent (%) increase in sum of longest diameter of target lesions compared to baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Metastatic colorectal cancer * Receiving Xeloda according to registered indication Exclusion Criteria: * Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.