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Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (APPROCHE ORL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01104714
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

April 14, 2010
April 15, 2010
March 26, 2015
April 2010
July 2014   (Final data collection date for primary outcome measure)
%change in tumor volume before and after chemotherapy (baseline versus 62 days) [ Time Frame: 62 days ]
Tumor volume is calculated according to Labadie et al 2000
Same as current
Complete list of historical versions of study NCT01104714 on Archive Site
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Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Surplus blood, tumor tissue from biopsies, and DNA will be stocked in the Biothèque of the Nîmes University Hospital
Non-Probability Sample
The patients included in this study have been diagnosed with an advanced stage squamous cell carcinoma in the buccal, oropharyngeal, laryngeal or hypopharyngeal areas.
  • Carcinoma, Squamous Cell
  • Mouth Neoplasms
  • Oropharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Hypopharyngeal Neoplasms
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All patients
As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2008-006874-14 ( EudraCT Number )
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Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
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Principal Investigator: Benjamin Lallemant, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2015