ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01104714
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Carcinoma, Squamous Cell Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms Hypopharyngeal Neoplasms

Study Design
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
Study Start Date : April 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. %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


Biospecimen Retention:   Samples With DNA
Surplus blood, tumor tissue from biopsies, and DNA will be stocked in the Biothèque of the Nîmes University Hospital

Eligibility Criteria
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients included in this study have been diagnosed with an advanced stage squamous cell carcinoma in the buccal, oropharyngeal, laryngeal or hypopharyngeal areas.
Criteria

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
Contacts and Locations
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104714


Locations
France
CH d'Alès
Alès, France, 30103
CHU de Bordeaux - Groupe Hospitalier Saint-André
Bordeaux, France, 33075
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
CHU de Grenoble
Grenoble cedex 09, France, 38043
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille Cedex, France, 59020
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier cedex 5, France, 34295
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
Montpellier cedex 5, France, 34298
Centre Antoine Lacassagne
Nice cedex 2, France, 06189
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France, 30029
CHRU de Toulouse - Hôpital Purpan
Toulouse Cedex 9, France, 31059
Centre de Lutte Contre le Cancer - Institut Claudius Regaud
Toulouse Cedex, France, 31052
Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud
Toulouse, France, 31052
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, France, 31059
CHRU de Toulouse - Hôpital Larrey
Toulouse, France, 31059
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Benjamin Lallemant, MD Centre Hospitalier Universitaire de Nîmes
More Information
Go to 
Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01104714     History of Changes
Other Study ID Numbers: LOCAL/2008/BL-01
2008-006874-14 ( EudraCT Number )
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Laryngeal Neoplasms
Oropharyngeal Neoplasms
Mouth Neoplasms
Hypopharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Otorhinolaryngologic Neoplasms
 Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Pharyngeal Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Mouth Diseases