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CompletedNCT01268878OTOHTPFUpdated Jan 3, 2014

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

An observational study in Squamous Cell Head and Neck Carcinoma, sponsored by Groupe Oncologie Radiotherapie Tete et Cou. Completed at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-03.

Sponsored by Groupe Oncologie Radiotherapie Tete et Cou · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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 .
02

Conditions studied

  • Squamous Cell Head and Neck Carcinoma

Keywords

  • effect of febrile neutropenia resulting chemotherapy by TPF
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 130 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Groupe Oncologie Radiotherapie Tete et Cou is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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,

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
06

What researchers measure

Primary outcomes

  1. biologic blood counts

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

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

07

Study locations

18 sites
  • Institut Sainte Catherine
    Avignon, 84082, France
  • Centre Hospitalier Universitaire
    Besancon, 25000, France
  • Polyclinique de Bordeaux Nord
    Bordeaux, 33077, France
  • Centre Hospitalier Universitaire
    Caen, 14033, France
  • Centre Jean Perrin
    Clermont Ferrand, 63011, France
  • Centre Hospitalier
    Draguignan, 83300, France
  • Centre Hospitalier de Vendée
    La Roche sur Yon, 85925, France
  • Centre Guillaume le Conquerant
    Le Havre, 76600, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Centre Hospitalier
    Lorient, 56000, France
  • Centre Leon Berard
    Lyon, 69008, France
  • Centre Antoine Lacassagne
    Nice, 06189, France
  • Groupe Hospitalier Pitié Salpétrière
    Paris, 75651, France
  • Institut Jean Godinot
    Reims, 51056, France
  • Centre Eugene Marquis
    Rennes, 35042, France
  • Clinique Armoricaine
    Saint Brieuc, 22015, France
  • Centre René Gauducheau
    Saint Herblain, 44885, France
  • Centre Hospitalier Bretonneau
    Tours, 37044, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01268878
Lead sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Responsible party
Sponsor
First posted
Dec 31, 2010
Start date
Jun 2010
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jan 3, 2014

Study contacts

ROLLAND Frederic, MD
principal investigator · GORTEC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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