Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers

Carcinoma, Squamous Cell Clinical Trial

— APPROCHE ORL  

Official title:

Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104714
• Other study ID #: LOCAL/2008/BL-01
• Secondary ID: 2008-006874-14
• Status: Completed
• Phase: N/A
• First received: April 14, 2010
• Last updated: March 25, 2015
• Start date: April 2010
• Est. completion date: July 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	CH d'Alès	Alès
France	CHU de Bordeaux - Groupe Hospitalier Pellegrin	Bordeaux
France	CHU de Bordeaux - Groupe Hospitalier Saint-André	Bordeaux
France	CHU de Grenoble	Grenoble cedex 09
France	Centre de Lutte Contre le Cancer - Centre Oscar Lambret	Lille Cedex
France	Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque	Montpellier cedex 5
France	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier cedex 5
France	Centre Antoine Lacassagne	Nice cedex 2
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse
France	CHRU de Toulouse - Hôpital Larrey	Toulouse
France	Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud	Toulouse
France	Centre de Lutte Contre le Cancer - Institut Claudius Regaud	Toulouse Cedex
France	CHRU de Toulouse - Hôpital Purpan	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%change in tumor volume before and after chemotherapy (baseline versus 62 days)	Tumor volume is calculated according to Labadie et al 2000	62 days	No