Squamous Cell Head and Neck CarcinomaOTOHTPFNCT01268878
Hematologic Toxicity Observation of the Docetaxel+ Cisplatin+ Fluorouracil (TPF)Medical Protocol
An observational study of Squamous Cell Head and Neck Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 18 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Head and Neck Carcinoma
- How many people
- 130 participants
- Where
- 18 sitesFrance
- Study dates
- Jun 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people who undergo first traitement by chemotherapy (docetaxel+cisplatin+-FU) for head and neck cell carcinoma, whom age is over eighteen,
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Institut Sainte Catherine
Avignon, 84082
Centre Hospitalier Universitaire
Besançon, 25000
Polyclinique de Bordeaux Nord
Bordeaux, 33077
Centre Hospitalier Universitaire
Caen, 14033
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre Hospitalier
Draguignan, 83300
Centre Hospitalier de Vendée
La Roche-sur-Yon, 85925
Centre Guillaume le Conquerant
Le Havre, 76600
Centre Oscar Lambret
Lille, 59020
Centre Hospitalier
Lorient, 56000
Centre Leon Berard
Lyon, 69008
Centre Antoine Lacassagne
Nice, 06189
Groupe Hospitalier Pitié Salpétrière
Paris, 75651
Institut Jean Godinot
Reims, 51056
Centre Eugene Marquis
Rennes, 35042
Clinique Armoricaine
Saint-Brieuc, 22015
Centre René Gauducheau
Saint-Herblain, 44885
Centre Hospitalier Bretonneau
Tours, 37044
About this study
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
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 .
- Conditions
- Squamous Cell Head and Neck Carcinoma
- Keywords
- effect of febrile neutropenia resulting chemotherapy by TPF
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
biologic blood counts
evaluation of medical status evaluation of hematologic toxicity description of clinic toxicity: fever, sepsis..
Measured: blood test before every chemotherapy up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROLLAND Frederic, MD, Principal investigator, GORTEC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268878
- Sponsor's protocol ID
- GORTEC 2010-01
- Acronym
- OTOHTPF
- Status last verified
- Jan 2014
- First submitted
- 29 Dec 2010
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01268878
- Acronym / sponsor ID
- OTOHTPF / GORTEC 2010-01
- Conditions
- Squamous Cell Head and Neck Carcinoma
- Keywords
- effect of febrile neutropenia resulting chemotherapy by TPF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ending of this study is to describe the effect of febrile neutropenia on patients who receive a chemotherapy by docetaxel+cisplatin+fluorouracil(TPF).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people who undergo first traitement by chemotherapy (docetaxel+cisplatin+-FU) for head and neck cell carcinoma, whom age is over eighteen,
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROLLAND Frederic, MD principal investigator
GORTEC
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Head and Neck Carcinoma, run by Groupe Oncologie Radiotherapie Tete et Cou at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biologic blood counts (time frame: blood test before every chemotherapy up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.