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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Head and Neck Carcinoma

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Trial Information

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


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 .


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

biologic blood counts

Outcome Description:

evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: feber, sepsis..

Outcome Time Frame:

blood test before every chemotherapy up to 4 months

Safety Issue:

Yes

Principal Investigator

ROLLAND Frederic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GORTEC

Authority:

France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:

GORTEC 2010-01

NCT ID:

NCT01268878

Start Date:

June 2010

Completion Date:

May 2012

Related Keywords:

  • Squamous Cell Head and Neck Carcinoma
  • effect of febrile neutropenia resulting chemotherapy by TPF
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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