Clinical trial · Interventional
Biomarkers in Predicting Neurotoxicity in Patients With Colorectal Cancer Receiving Oxaliplatin
Characterization and Research of Predictive Markers of Neurotoxicity During Treatment With Oxaliplatin in Colorectal Carcinoma: a Genetic and Proteomic Approach. Phase II Multicenter Study
- 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)
RATIONALE: Studying samples of blood in the laboratory from patients receiving oxaliplatin for cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to neurotoxicity. PURPOSE: This phase II trial is studying biomarkers in predicting neurotoxicity in patients with colorectal cancer receiving oxaliplatin.
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 |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Neurotoxicity | — | UNRESOLVED | — |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation of genetic profiles and peptide, protein, and neurotrophic factors with neurological toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Requires treatment with oxaliplatin (as part of a FOLFOX regimen) * No brain metastases or symptomatic meningitis PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Life expectancy \> 3 months * ANC ≥ 1 x 10\^9/L * Platelet count ≥ 100 x 10\^9/L * Total bilirubin ≤ 2 times upper limit of normal (ULN) * Transaminases ≤ 3 times ULN * Alkaline phosphatase ≤ 5 times ULN * Not pregnant or nursing * Fertile patients must use effective contraception * No prior or concurrent clinical neuropathy (regardless of the etiology) * No dihydropyrimidine dehydrogenase deficiency * No psychiatric illness that would preclude comprehension of the study or of the informed consent * No other severe illness that may worsen during treatment, including unstable cardiac disease, myocardial infarction within the past 6 months, or active uncontrolled infection * No psychological, social, familial, or geographical reason that would preclude study follow-up * Other cancer within the past 5 years allowed provided treatment did not include platinum derivatives or taxanes PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior chemotherapy allowed (except for platinum derivatives or taxanes)
References
Publications (0)
Data not yet available