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Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers


N/A
30 Years
80 Years
Open (Enrolling)
Both
Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms

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Trial Information

Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers


Inclusion Criteria:



- Squamous cell carcinoma originating in the mouth, oropharynx, larynx or hypopharynx
has been histologically documented.

- The disease is at one of the following UICC 2002 stages, regardless of ganglion
status: T3 MO or T4 MO

- Treatment via chemotherapy, radiotherapy or surgery (except for the diagnostic
biopsy) has not started

- The pluridisciplinary committee as ruled out surgical options for technical or
functional reasons

- Absence of distant metastases

- OMS general health status between 0 and 2

- Patient has given informed consent

- Patient is affiliated with a social security system

Exclusion Criteria:

- Undifferentiated squamous cell carcinomas in the nasopharynx (UCNT)

- Another cancer priorly treated with one of the following chemotherapies: Docetaxel,
Cisplatin, 5-Fluorouracile

- Creatininemia > 2 mg/dl and/or creatinine clearance < 60ml/min

- Patient under guardianship

- Presence of another severe pathology including:

- severe or chronic cardiac, renal and/or hepatic insufficiencies

- severe medullary hypoplasia

- severe autoimmune disease

- psychosis or senility

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

%change in tumor volume before and after chemotherapy (baseline versus 62 days)

Outcome Description:

Tumor volume is calculated according to Labadie et al 2000

Outcome Time Frame:

62 days

Safety Issue:

No

Principal Investigator

Benjamin Lallemant, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

LOCAL/2008/BL-01

NCT ID:

NCT01104714

Start Date:

April 2010

Completion Date:

March 2014

Related Keywords:

  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Hypopharyngeal Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms

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