Clinical trial · Observational
Retrospective Evaluation of 5-FU Exposure Optimization in CRC Patients
Retrospective Data Comparison of Toxicity and Efficacy in Colorectal Cancer (CRC) Patients Managed With and Without 5-FU Exposure Optimization Testing
- 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)
The primary objective of this study is to evaluate whether the management of colorectal cancer (CRC) patients with 5-fluorouracil (5-FU) exposure optimization testing reduces 5-FU related toxicities and improves outcomes compared to the current standard of care. A secondary objective is to characterize the variability of 5-FU levels among CRC patients managed with 5-FU exposure optimization testing and the impact of such management on 5-FU plasma levels and drug doses during the course of chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 5-FU Containing Therapy Regimens | — | UNRESOLVED | — |
| Adjuvant Colorectal Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PK-Guided Cohort
- description
- CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was monitored and optimized using PK-guided dose adjustment.
- label
- BSA Cohort
- description
- CRC patients who were treated with 5-FU containing therapy regimen where 5-FU dosing was done according to body surface area (BSA) and no PK monitoring was performed.
Primary outcomes (5)
- measure
- Variability of 5-FU plasma levels (exposure)
- timeFrame
- At each cycle after initiation of 5-FU containing therapy, or approximately every 1 - 2 weeks, depending on the 5-FU infusion schedule, for up to ~12 cycles (~24 weeks) total.
- description
- At each treatment cycle (i.e. Cycle 1, Cycle 2, Cycle 3, etc.), we will plot the 5-FU exposure (i.e. AUC value) and determine the average, median, standard deviation, and percent coefficient of variation (%CV). These statistics will also be determined for all 5-FU exposure values combined.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients 18 years of age or older. * Patients with histologically confirmed colorectal cancer who were treated with an infusional 5-FU regimen between May 1, 2009 and December 31, 2013. * PK-Guided Cohort: Patients monitored with 5-FU PK-testing at a minimum of two administrations of 5-FU throughout the course of a single infusional 5-FU containing treatment regimen. * BSA Cohort: Patients who received infusional 5-FU doses calculated based on their BSA. Exclusion Criteria: * Patients less than 18 years of age. * Patients with concurrent treatment of other active malignancies. * Patients that underwent radiation therapy concurrently with chemotherapy.
References
Publications (0)
Data not yet available