Colon CancerIgESNCT01436617
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
An observational study of Colon Cancer and Head and Neck Cancer, run by Centre Francois Baclesse at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Head and Neck Cancer, Allergic Reaction
- What is being tested?
- blood sample
- How many people
- 303 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2010to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab
Who may be able to join
- 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.
Who cannot join
- Patients previously treated with cetuximab,
- A person deprived of liberty or under supervision.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU
Amiens, 80054
Centre hospitalier
Bayeux, 14400
CHU
Caen, 14033
Centre François Baclesse
Caen, 14076
Centre Georges-François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
CHRU Lille
Lille, 59037
CHU Charles Nicolle
Rouen, 76000
Centre Henri Becquerel
Rouen, 76038
Centre Paul Strauss
Strasbourg, 67065
About this study
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.
- Conditions
- Colon Cancer, Head and Neck Cancer, Allergic Reaction
- Being tested
- blood sample
- Keywords
- cancer, colon, Head and neck, cetuximab, anti-cetuximab dosage
- Medical subject headings
- Colonic Neoplasms, Head and Neck Neoplasms, Hypersensitivity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
The IgE anti cetuximab test will then be conducted by an ELISA test
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Caen
- Responsible party
- Sponsor
- Investigators
- GERVAIS Radj, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01436617
- Sponsor's protocol ID
- IgES
- Acronym
- IgES
- Status last verified
- Mar 2013
- First submitted
- 14 Sep 2011
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01436617
- Acronym / sponsor ID
- IgES / IgES
- Conditions
- Colon Cancer, Head and Neck Cancer, Allergic Reaction
- Keywords
- cancer, colon, Head and neck, cetuximab, anti-cetuximab dosage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- University Hospital, Caen
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon cancer or upper aero-digestive tract and candidates for treatment with cetuximab
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- Patients previously treated with cetuximab,
- A person deprived of liberty or under supervision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleThe IgE anti cetuximab test will then be conducted by an ELISA test | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GERVAIS Radj, MD principal investigator
Centre François Baclesse
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Head and Neck Cancer, run by Centre Francois Baclesse at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate the utility of an IgE anti-cetuximab test in the treatment strategy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2013.