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Completed

NCT Number: NCT01268878

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

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

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Key information

Conditions

Squamous Cell Head and Neck Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Sainte Catherine, Avignon, France

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. biologic blood counts

    Time frame: blood test before every chemotherapy up to 4 months

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

Sponsors and collaborators

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Other

Registry information

Official study 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

Acronym: OTOHTPF

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 31, 2010
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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