Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol

Squamous Cell Head and Neck Carcinoma Clinical Trial

— OTOHTPF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268878
• Other study ID #: GORTEC 2010-01
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: January 2, 2014
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2014
• Source: Groupe Oncologie Radiotherapie Tete et Cou
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Febrile Neutropenia
• Squamous Cell Head and Neck Carcinoma

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier Universitaire	Besancon
France	Polyclinique de Bordeaux Nord	Bordeaux
France	Centre Hospitalier Universitaire	Caen
France	Centre Jean Perrin	Clermont Ferrand
France	Centre Hospitalier	Draguignan
France	Centre Hospitalier de Vendée	La Roche sur Yon
France	Centre Guillaume le Conquerant	Le Havre
France	Centre Oscar Lambret	Lille
France	Centre Hospitalier	Lorient
France	Centre Leon Berard	Lyon
France	Centre Antoine Lacassagne	Nice
France	Groupe Hospitalier Pitié Salpétrière	Paris
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Clinique Armoricaine	Saint Brieuc
France	Centre René Gauducheau	Saint Herblain
France	Centre Hospitalier Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	biologic blood counts	evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..	blood test before every chemotherapy up to 4 months	Yes