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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01436617
Date of registration: 14/09/2011
Prospective Registration: No
Primary sponsor: Centre Francois Baclesse
Public title: 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
Scientific title: 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
Date of first enrolment: January 2010
Target sample size: 303
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01436617
Study type:  Observational
Study design:  Time Perspective: Prospective  
Phase: 
Countries of recruitment
France
Contacts
Name:     GERVAIS Radj, MD
Address: 
Telephone:
Email:
Affiliation:  Centre François Baclesse
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Allergic Reaction
Colon Cancer
Head and Neck Cancer
Intervention(s)
Other: blood sample
Primary Outcome(s)
Validate the utility of an IgE anti-cetuximab test in the treatment strategy [Time Frame: 3 years]
Secondary Outcome(s)
Secondary ID(s)
IgES
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Hospital, Caen
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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