Clinical trial · Observational
Assessing the Value of a Dosage of Anti-cetuximab in the Therapeutic Management of Patients With Colon Cancer or Upper Aero-digestive Tract and Candidates for Treatment With Cetuximab
NCT01436617CI-TRIAL-00009676IgEScompletedClinicalTrials.gov clinicaltrialsProvenance
- 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 main objective of this study is to validate the utility of IgE anti-cetuximab in the treatment strategy to identify patients at risk for a severe allergic reaction to cetuximab (grade 3 or 4 of the classification of NCI) and thus reduce the incidence of severe reactions.
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 |
|---|---|---|---|
| Allergic Reaction | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validate the utility of an IgE anti-cetuximab test in the treatment strategy
- timeFrame
- 3 years
- description
- We hypothesize that a positive specific IgE assay predicts the occurrence of an allergic reaction during the first dose of cetuximab. Thus, in population areas where the prevalence of specific IgE positive plasma is higher, the use of alternative therapies in patients with a positive test would reduce the incidence of anaphylactic reactions to cetuximab. If the use of specific IgE anti-cetuximab in the treatment strategy is effective, there will be reduction in the incidence of anaphylaxis to cetuximab in the participating centers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient informed consent, * Patient aged over 18 years * Patients with a WHO performance status ≤ 2, * Colon cancer or upper aero-digestive tract cytologically or histologically proven * Patients with an indication to the theoretical use of cetuximab for colon neoplasia or upper aero-digestive tract, * Haematological and biochemical compatible with combination therapy with cetuximab. Exclusion Criteria: * Patients previously treated with cetuximab, * A person deprived of liberty or under supervision.
References
Publications (0)
Data not yet available
No reference posted for this study.