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

January 2, 2014 updated by: Groupe Oncologie Radiotherapie Tete et Cou

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

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Besancon, France, 25000
        • Centre Hospitalier Universitaire
      • Bordeaux, France, 33077
        • Polyclinique de Bordeaux Nord
      • Caen, France, 14033
        • Centre Hospitalier Universitaire
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin
      • Draguignan, France, 83300
        • Centre Hospitalier
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier de Vendée
      • Le Havre, France, 76600
        • Centre Guillaume Le Conquerant
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lorient, France, 56000
        • Centre Hospitalier
      • Lyon, France, 69008
        • Centre Léon Berard
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75651
        • Groupe Hospitalier Pitié Salpêtrière
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Saint Brieuc, France, 22015
        • Clinique Armoricaine
      • Saint Herblain, France, 44885
        • Centre Rene Gauducheau
      • Tours, France, 37044
        • Centre Hospitalier Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

people who undergo first traitement by chemotherapy (docetaxel+cisplatin+-FU) for head and neck cell carcinoma, whom age is over eighteen,

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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..
blood test before every chemotherapy up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: ROLLAND Frederic, MD, GORTEC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 29, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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