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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01104714

Acronym

APPROCHE ORL

Enrollment

Registered

2010-04-15

Start date

2010-04-30

Completion date

2014-07-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
%change in tumor volume before and after chemotherapy (baseline versus 62 days)	62 days	Tumor volume is calculated according to Labadie et al 2000

Countries

France

Outcome results