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)

March 7, 2013 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

303

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU
      • Bayeux, France, 14400
        • Centre Hospitalier
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Caen, France, 14033
        • CHU
      • Dijon, France, 21079
        • Centre Georges-François Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lille, France, 59037
        • Chru Lille
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76000
        • CHU Charles Nicolle
      • Strasbourg, France, 67065
        • Centre Paul Strauss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the utility of an IgE anti-cetuximab test in the treatment strategy
Time Frame: 3 years

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

University Hospital, Caen

Investigators

  • Principal Investigator: GERVAIS Radj, MD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 16, 2011

First Posted (Estimate)

September 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IgES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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