Clinical trial · Interventional
Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer
Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer
NCT00905047CI-TRIAL-00105504COLOCROSScompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments. Another objective of the trial is to assess and compare the safety of each treatment.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TEGAFUR URACIL - FOLINIC ACID | Drug | — | UNRESOLVED |
| XELODA | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- XELODA
- interventionNames
- Drug: XELODA
- type
- OTHER
- label
- UFT
- interventionNames
- Drug: TEGAFUR URACIL - FOLINIC ACID
Primary outcomes (1)
- measure
- patients preference after randomization and cross-over
- timeFrame
- after 2 cycles of treatment
Secondary outcomes (1)
- measure
- safety of each treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced or metastatic colo-rectal cancer * Age \> or = 18 years old * PS-WHO \< or = 2 * Polynuclear neutrophil leukocytes \> or = 1500/mm3, platelets \> or = 100000/mm3 * Total bilirubin \< or = 3 ULN, ASAT-ALAT \< or = 2.5 ULN * Effective contraception * Written informed consent signed Exclusion Criteria: * Concomitant radiotherapy * Contraindication to fluoropyrimidines * Treatment with sorivudine and its chemical analogs such as brivudine * Severe hepatic insufficiency * Severe renal insufficiency * Pregnant or lactating woman * Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
References
Publications (0)
Data not yet available
No reference posted for this study.