Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (APPROCHE ORL)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01104714

LOCAL/2008/BL-01

2008-006874-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

90 participants in 1 patient group

All patients

Description:

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