Clinical trial NCT01268878: Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Head and Neck Carcinoma
Keywords: effect of febrile neutropenia resulting chemotherapy by TPF
Lead sponsor: Groupe Oncologie Radiotherapie Tete et Cou
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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,

Brief summary: The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).

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 .

Eligibility criteria: 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

Primary outcomes:
measure: biologic blood counts
timeFrame: blood test before every chemotherapy up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Centre Hospitalier Universitaire
city: Bordeaux
country: France
facility: Polyclinique de Bordeaux Nord
city: Caen
country: France
facility: Centre Hospitalier Universitaire
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Draguignan
country: France
facility: Centre Hospitalier
city: La Roche sur Yon
country: France
facility: Centre Hospitalier de Vendée
city: Le Havre
country: France
facility: Centre Guillaume le Conquerant
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lorient
country: France
facility: Centre Hospitalier
city: Lyon
country: France
facility: Centre Leon Berard
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Groupe Hospitalier Pitié Salpétrière
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint Brieuc
country: France
facility: Clinique Armoricaine
city: Saint Herblain
country: France
facility: Centre René Gauducheau
city: Tours
country: France
facility: Centre Hospitalier Bretonneau
Study officials:
affiliation: GORTEC
name: ROLLAND Frederic, MD
role: PRINCIPAL_INVESTIGATOR
References: