Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers

Completed

• Conditions: Mouth Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Carcinoma, Squamous Cell; Hypopharyngeal Neoplasms

• Registration Number: NCT01104714
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (14)

CH d'Alès; 🇫🇷 Alès, France

CHU de Bordeaux - Groupe Hospitalier Saint-André; 🇫🇷 Bordeaux, France

CHU de Bordeaux - Groupe Hospitalier Pellegrin; 🇫🇷 Bordeaux, France

Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud; 🇫🇷 Toulouse, France

CHU de Grenoble; 🇫🇷 Grenoble cedex 09, France

Centre de Lutte Contre le Cancer - Centre Oscar Lambret; 🇫🇷 Lille Cedex, France

CHU de Montpellier - Hôpital Gui de Chauliac; 🇫🇷 Montpellier cedex 5, France

Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque; 🇫🇷 Montpellier cedex 5, France

Centre Antoine Lacassagne; 🇫🇷 Nice cedex 2, France

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes, France

CHRU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse Cedex 9, France

Centre de Lutte Contre le Cancer - Institut Claudius Regaud; 🇫🇷 Toulouse Cedex, France

CHRU de Toulouse - Hôpital de Rangueil; 🇫🇷 Toulouse, France

CHRU de Toulouse - Hôpital Larrey; 🇫🇷 Toulouse, France