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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)

This study has been completed.
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01436617
First received: September 14, 2011
Last updated: March 7, 2013
Last verified: March 2013
History of Changes

September 14, 2011
March 7, 2013
January 2010
March 2013   (final data collection date for primary outcome measure)
Validate the utility of an IgE anti-cetuximab test in the treatment strategy [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.
Same as current
Complete list of historical versions of study NCT01436617 on ClinicalTrials.gov Archive Site
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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
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

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.
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Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab
  • Colon Cancer
  • Head and Neck Cancer
  • Allergic Reaction
Other: blood sample
The IgE anti cetuximab test will then be conducted by an ELISA test
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01436617
IgES
Yes
Centre Francois Baclesse
Centre Francois Baclesse
University Hospital, Caen
Principal Investigator: GERVAIS Radj, MD Centre François Baclesse
Centre Francois Baclesse
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP