Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol
OTOHTPF
1 other identifier
observational
130
1 country
18
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2010
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 29, 2010
CompletedFirst Posted
Study publicly available on registry
December 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJanuary 3, 2014
January 1, 2014
1.4 years
December 29, 2010
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
biologic blood counts
evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..
blood test before every chemotherapy up to 4 months
Eligibility Criteria
people who undergo first traitement by chemotherapy (docetaxel+cisplatin+-FU) for head and neck cell carcinoma, whom age is over eighteen,
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Institut Sainte Catherine
Avignon, 84082, France
Centre Hospitalier Universitaire
Besançon, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROLLAND Frederic, MD
GORTEC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2010
First Posted
December 31, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
January 3, 2014
Record last verified: 2014-01