- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01268878
Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol (OTOHTPF)
January 2, 2014 updated by: Groupe Oncologie Radiotherapie Tete et Cou
Hematologic Toxicity Observation of the TPF Medical Protocol. Description of the Impact of Febrile Neutropenia in Patients Who Receive the Chemotherapy of the TPF Medical Protocol in Head and Neck Cell Carcinoma
The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).
Study Overview
Status
Completed
Conditions
Detailed Description
In this study we will describe
- habits of medical staff in prescription of growth factors or antibiotic prophylaxis
- ratio of patients treated by growth factors in primary or secondary prophylaxis
- ratio of patients treated in primary prophylaxis who present a febrile neutropenia
- ratio of patients who need to be hospitalized and the duration of those hospitalizations.
- causes of lateness, of decreasing, and of stop of chemotherapy
- antibiotic and growth factors prophylaxis tolerance .
Study Type
Observational
Enrollment (Actual)
130
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
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Avignon, France, 84082
- Institut Sainte Catherine
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Besancon, France, 25000
- Centre Hospitalier Universitaire
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Bordeaux, France, 33077
- Polyclinique de Bordeaux Nord
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Caen, France, 14033
- Centre Hospitalier Universitaire
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Clermont Ferrand, France, 63011
- Centre Jean Perrin
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Draguignan, France, 83300
- Centre Hospitalier
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La Roche sur Yon, France, 85925
- Centre Hospitalier de Vendée
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Le Havre, France, 76600
- Centre Guillaume Le Conquerant
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Lille, France, 59020
- Centre Oscar Lambret
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Lorient, France, 56000
- Centre Hospitalier
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Lyon, France, 69008
- Centre Léon Berard
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Nice, France, 06189
- Centre Antoine Lacassagne
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Paris, France, 75651
- Groupe Hospitalier Pitié Salpêtrière
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Reims, France, 51056
- Institut Jean Godinot
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Rennes, France, 35042
- Centre Eugene Marquis
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Saint Brieuc, France, 22015
- Clinique Armoricaine
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Saint Herblain, France, 44885
- Centre Rene Gauducheau
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Tours, France, 37044
- Centre Hospitalier Bretonneau
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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
people who undergo first traitement by chemotherapy (docetaxel+cisplatin+-FU) for head and neck cell carcinoma, whom age is over eighteen,
Description
Inclusion Criteria:
- patients with histologically proved head and neck squamous cell carcinoma
- age: more than 18
- patients who are beginning a chemotherapy (docetaxel+cisplatin+ 5FU)
- patients must have been informed of automatic data processing concerning them.
Exclusion Criteria:
- previous chemotherapy for the head and neck squamous cell carcinoma
- previous chemotherapy for an other cancer in the two years before
- intercurrent illness that could significantly interfere with chemotherapy such as HIV infection, infection or active febrile illness, a chronic intestinal disease
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biologic blood counts
Time Frame: blood test before every chemotherapy up to 4 months
|
evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..
|
blood test before every chemotherapy up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: ROLLAND Frederic, MD, GORTEC
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
June 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
December 29, 2010
First Submitted That Met QC Criteria
December 30, 2010
First Posted (Estimate)
December 31, 2010
Study Record Updates
Last Update Posted (Estimate)
January 3, 2014
Last Update Submitted That Met QC Criteria
January 2, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GORTEC 2010-01
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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