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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01268878

Acronym

OTOHTPF

Enrollment

130

Registered

2010-12-31

Start date

2010-06-30

Completion date

2011-11-30

Last updated

2014-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Head and Neck Carcinoma

Keywords

effect of febrile neutropenia resulting chemotherapy by TPF

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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..

Countries

France

Outcome results