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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier:
NCT01268878
First received: December 29, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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


Condition
Squamous Cell Head and Neck Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Groupe Oncologie Radiotherapie Tete et Cou:

Primary Outcome Measures:
  • biologic blood counts [ Time Frame: blood test before every chemotherapy up to 4 months ] [ Designated as safety issue: Yes ]
    evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..


Enrollment: 130
Study Start Date: June 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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 .
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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,

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268878

Locations
France
Institut Sainte Catherine
Avignon, France, 84082
Centre Hospitalier Universitaire
Besancon, France, 25000
Polyclinique de Bordeaux Nord
Bordeaux, France, 33077
Centre Hospitalier Universitaire
Caen, France, 14033
Centre Jean Perrin
Clermont Ferrand, France, 63011
Centre Hospitalier
Draguignan, France, 83300
Centre Hospitalier de Vendée
La Roche sur Yon, France, 85925
Centre Guillaume le Conquerant
Le Havre, France, 76600
Centre Oscar Lambret
Lille, France, 59020
Centre Hospitalier
Lorient, France, 56000
Centre Leon Berard
Lyon, France, 69008
Centre Antoine Lacassagne
Nice, France, 06189
Groupe Hospitalier Pitié Salpétrière
Paris, France, 75651
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35042
Clinique Armoricaine
Saint Brieuc, France, 22015
Centre René Gauducheau
Saint Herblain, France, 44885
Centre Hospitalier Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Groupe Oncologie Radiotherapie Tete et Cou
Investigators
Principal Investigator: ROLLAND Frederic, MD GORTEC
  More Information

No publications provided

Responsible Party: Groupe Oncologie Radiotherapie Tete et Cou
ClinicalTrials.gov Identifier: NCT01268878     History of Changes
Other Study ID Numbers: GORTEC 2010-01
Study First Received: December 29, 2010
Last Updated: January 2, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Groupe Oncologie Radiotherapie Tete et Cou:
effect of febrile neutropenia resulting chemotherapy by TPF

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on July 20, 2014