Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
APPROCHE ORL
Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
2 other identifiers
observational
90
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2010
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 26, 2015
March 1, 2015
4.3 years
April 14, 2010
March 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
%change in tumor volume before and after chemotherapy (baseline versus 62 days)
Tumor volume is calculated according to Labadie et al 2000
62 days
Study Arms (1)
All patients
As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.
Eligibility Criteria
The patients included in this study have been diagnosed with an advanced stage squamous cell carcinoma in the buccal, oropharyngeal, laryngeal or hypopharyngeal areas.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
CH d'Alès
Alès, 30103, France
CHU de Bordeaux - Groupe Hospitalier Saint-André
Bordeaux, 33075, France
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076, France
CHU de Grenoble
Grenoble, 38043, France
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, 59020, France
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295, France
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
Montpellier, 34298, France
Centre Antoine Lacassagne
Nice, 06189, France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Centre de Lutte Contre le Cancer - Institut Claudius Regaud
Toulouse, 31052, France
Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud
Toulouse, 31052, France
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059, France
CHRU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
CHRU de Toulouse - Hôpital Purpan
Toulouse, 31059, France
Related 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.
PMID: 10696014BACKGROUND
Biospecimen
Surplus blood, tumor tissue from biopsies, and DNA will be stocked in the Biothèque of the Nîmes University Hospital
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Lallemant, MD
Centre Hospitalier Universitaire de Nîmes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 15, 2010
Study Start
April 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 26, 2015
Record last verified: 2015-03