Clinical trial NCT01104714: Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
Official title: Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Squamous Cell
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Hypopharyngeal Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients included in this study have been diagnosed with an advanced stage squamous cell carcinoma in the buccal, oropharyngeal, laryngeal or hypopharyngeal areas.

Brief summary: The purpose of this study is to determine if there is a correlation between tumor response after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional modifications.


Eligibility criteria: 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

Primary outcomes:
measure: %change in tumor volume before and after chemotherapy (baseline versus 62 days)
timeFrame: 62 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alès
country: France
facility: CH d'Alès
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Saint-André
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin
city: Grenoble cedex 09
country: France
facility: CHU de Grenoble
city: Lille Cedex
country: France
facility: Centre de Lutte Contre le Cancer - Centre Oscar Lambret
city: Montpellier cedex 5
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Montpellier cedex 5
country: France
facility: Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
city: Nice cedex 2
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Purpan
city: Toulouse Cedex
country: France
facility: Centre de Lutte Contre le Cancer - Institut Claudius Regaud
city: Toulouse
country: France
facility: Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud
city: Toulouse
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
city: Toulouse
country: France
facility: CHRU de Toulouse - Hôpital Larrey
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Benjamin Lallemant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labadie RF, Yarbrough WG, Weissler MC, Pillsbury HC, Mukherji SK. Nodal volume reduction after concurrent chemo- and radiotherapy: correlation between initial CT and histopathologic findings. AJNR Am J Neuroradiol. 2000 Feb;21(2):310-4.