Clinical trial · Interventional
Implementation of Pre-emptive Geno- and Phenotyping in 5-Fluorouracil- or Capecitabine-treated Patients
Implementation of Pre-emptive Geno- and Phenotyping in 5-Fluorouracil- or Capecitabine-treated Patients With the Aim of Reducing Toxicity
- 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 aim of this study is to investigate if the systematic implementation of pre-emptive geno- and phenotyping, and therefore a dose reduction based on the French guidelines and the literature during the first month of treatment, reduces grade 3 or greater toxicity in patients treated with 5-FU (5-fluorouracil) or capecitabine. Therefore, a monocentric, partial prospective and partial retrospective trail was designed.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Tumor | Anal Neoplasm | ALIAS | 0.90 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Stomach Tumor | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Dosage according to French guidelines
- interventionNames
- Drug: 5-Fluorouracil
- type
- EXPERIMENTAL
- label
- Group B
- description
- Dosage according to literature
- interventionNames
- Drug: 5-Fluorouracil
Primary outcomes (1)
- measure
- The frequency of severe fluoropyrimidine-related toxicity
- timeFrame
- about 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 18 years or older * WHO (world health organization) classification 0,1 or 2 * A suspected start with 5-FU or capecitabine in mono or combination therapy * The knowledge of the result of the geno and phenotyping before the start of the treatment Exclusion Criteria: * Not meeting inclusion criteria * Homozygote genotype or uracil 100 ng/ml or greater * The lacking of the result of the geno and / or phenotyping before the start of treatment * Patients who received 5-FU or capecitabine in the past
References
Publications (0)
Data not yet available