Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-07-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No