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

Completed

• Conditions: Squamous Cell Head and Neck Carcinoma

• Registration Number: NCT01268878
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

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 .

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
biologic blood counts	blood test before every chemotherapy up to 4 months	evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..

Trial Locations

Locations (16)

Centre Hospitalier Universitaire; 🇫🇷 Caen, France

Polyclinique de Bordeaux Nord; 🇫🇷 Bordeaux, France

Centre Guillaume le Conquerant; 🇫🇷 Le Havre, France

Centre Eugene Marquis; 🇫🇷 Rennes, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier de Vendée; 🇫🇷 La Roche sur Yon, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Groupe Hospitalier Pitié Salpétrière; 🇫🇷 Paris, France

Centre Hospitalier; 🇫🇷 Lorient, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Institut Jean Godinot; 🇫🇷 Reims, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France

Clinique Armoricaine; 🇫🇷 Saint Brieuc, France

Centre Leon Berard; 🇫🇷 Lyon, France

Centre Hospitalier Bretonneau; 🇫🇷 Tours, France