Clinical trial · Interventional
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile
- 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 intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration. The results of this identification determine the chemotherapy type: high-dose irinotecan or not.
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5 fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- tumor response rate
- timeFrame
- during the treatment
Secondary outcomes (2)
- measure
- toxicity
- timeFrame
- during the treatment
- measure
- pharmacokinetics
- timeFrame
- during the first administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice * Ages between 18 and 85 years * Histologically confirmed colorectal cancer * No treatment for metastatic disease * No irinotecan previously administered * World Health Organization (WHO) performance status \< 3 * Laboratory values : * neutrophils \> 1.5 x 10\^9/L; * platelet count \> 100 x 10\^9/L; * serum creatinine \< 130µmol/L; * serum bilirubin \< 2 x upper limit of normal (ULN); * ASAT and ALAT \< 2.5 x ULN; * alkaline phosphatase \< 5 x ULN. * At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria Exclusion Criteria: * History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder. * Other concomitant anticancer therapy. * Pregnant or lactating women. * Women of childbearing potential unless using a reliable and appropriate contraceptive method. * Symptomatic cerebral or leptospiral metastasis. * Intestinal obstruction. * Uncontrolled seizures (diabetes, severe infection). * Clinically significant cardiac disease. * Central nervous system disorders or severe psychiatric disability. * Participation in any investigational study within 4 weeks.
References
Publications (1)
- BACKGROUNDIyer L, Das S, Janisch L, Wen M, Ramirez J, Karrison T, Fleming GF, Vokes EE, Schilsky RL, Ratain MJ. UGT1A1*28 polymorphism as a determinant of irinotecan disposition and toxicity. Pharmacogenomics J. 2002;2(1):43-7. doi: 10.1038/sj.tpj.6500072. PMID 11990381