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

NCT ID: NCT01436617

Last Updated: 2013-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Head and Neck Cancer Allergic Reaction

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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blood sample

The IgE anti cetuximab test will then be conducted by an ELISA test

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GERVAIS Radj, MD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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CHU

Amiens, , France

Site Status

Centre hospitalier

Bayeux, , France

Site Status

CHU

Caen, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Georges-François Leclerc

Dijon, , France

Site Status

Centre Oscar Lambret

Lille, , France

Site Status

CHRU Lille

Lille, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre Paul Strauss

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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IgES

Identifier Type: -

Identifier Source: org_study_id

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