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
IgES
1 other identifier
observational
303
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 14, 2011
CompletedFirst Posted
Study publicly available on registry
September 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 8, 2013
March 1, 2013
3.2 years
September 14, 2011
March 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validate the utility of an IgE anti-cetuximab test in the treatment strategy
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.
3 years
Interventions
The IgE anti cetuximab test will then be conducted by an ELISA test
Eligibility Criteria
Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab
You may qualify if:
- 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.
You may not qualify if:
- Patients previously treated with cetuximab,
- A person deprived of liberty or under supervision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Francois Baclesselead
- University Hospital, Caencollaborator
Study Sites (10)
CHU
Amiens, 80054, France
Centre hospitalier
Bayeux, 14400, France
CHU
Caen, 14033, France
Centre François Baclesse
Caen, 14076, France
Centre Georges-François Leclerc
Dijon, 21079, France
Centre Oscar Lambret
Lille, 59020, France
CHRU Lille
Lille, 59037, France
CHU Charles Nicolle
Rouen, 76000, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Paul Strauss
Strasbourg, 67065, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GERVAIS Radj, MD
Centre François Baclesse
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2011
First Posted
September 19, 2011
Study Start
January 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
March 8, 2013
Record last verified: 2013-03