Skip to main content
OpenTrials
Completed

NCT Number: NCT01104714

Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Alès, Alès, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: APPROCHE ORL

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 15, 2010
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.