Trial record 2 of 50 for:
Open Studies | "Laryngeal Neoplasms"
Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (APPROCHE ORL)
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01104714
First received: April 14, 2010
Last updated: March 26, 2013
Last verified: March 2013
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Purpose
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 |
|---|
|
Carcinoma, Squamous Cell Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms Hypopharyngeal Neoplasms |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- %change in tumor volume before and after chemotherapy (baseline versus 62 days) [ Time Frame: 62 days ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All patients
As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104714
Contacts
| Contact: Benjamin Lallemant, MD | 33.4.66.68.32.73 | benjamin.lallemant@chu-nimes.fr |
Locations
| France | |
| CH d'Alès | Recruiting |
| Alès, France, 30103 | |
| Principal Investigator: Didier Cupissol, MD | |
| Sub-Investigator: Caroline Alovisetti, MD | |
| CHU de Bordeaux - Groupe Hospitalier Saint-André | Recruiting |
| Bordeaux, France, 33075 | |
| Sub-Investigator: Laurence Digue, MD | |
| CHU de Bordeaux - Groupe Hospitalier Pellegrin | Recruiting |
| Bordeaux, France, 33076 | |
| Principal Investigator: Erwan De Mones, MD | |
| Sub-Investigator: Sandrine Eimer, MD | |
| CHU de Grenoble | Recruiting |
| Grenoble cedex 09, France, 38043 | |
| Principal Investigator: Emile Reyt, MD | |
| Sub-Investigator: Christian Righini, MD | |
| Sub-Investigator: Claire Faure, MD | |
| Centre de Lutte Contre le Cancer - Centre Oscar Lambret | Recruiting |
| Lille Cedex, France, 59020 | |
| Principal Investigator: Marian Degardin, MD | |
| CHU de Montpellier - Hôpital Gui de Chauliac | Recruiting |
| Montpellier cedex 5, France, 34295 | |
| Principal Investigator: Renaud Garrel, MD | |
| Sub-Investigator: Valérie Costes, MD | |
| Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque | Recruiting |
| Montpellier cedex 5, France, 34298 | |
| Principal Investigator: Didier Cupissol, MD | |
| Centre Antoine Lacassagne | Recruiting |
| Nice cedex 2, France, 06189 | |
| Principal Investigator: Frédéric Peyrade, MD | |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Recruiting |
| Nîmes, France, 30029 | |
| Principal Investigator: Benjamin Lallemant, MD | |
| Sub-Investigator: Pascal Roger, MD | |
| Sub-Investigator: Sophie Kacha, MD | |
| Sub-Investigator: Guillaume Chambon, MD | |
| Sub-Investigator: Charles Debrigode, MD | |
| Sub-Investigator: Mounira El Demery, MD | |
| Sub-Investigator: Nicolas Molinari, PhD | |
| Sub-Investigator: Jean-Pierre Daurès, MD, PhD | |
| Sub-Investigator: Jean-Paul Brouillet, MD | |
| Sub-Investigator: Alexandre Evrard, MD | |
| CHRU de Toulouse - Hôpital Larrey | Recruiting |
| Toulouse, France, 31059 | |
| Principal Investigator: Sebastien Vergez, MD | |
| Sub-Investigator: Josiane Percodani, MD | |
| Sub-Investigator: Stéphanie Lozano, MD | |
| Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud | Recruiting |
| Toulouse, France, 31052 | |
| Principal Investigator: Etienne Chatelut, MD | |
| CHRU de Toulouse - Hôpital de Rangueil | Recruiting |
| Toulouse, France, 31059 | |
| Sub-Investigator: Emmanuelle Uro-Coste, MD | |
| Centre de Lutte Contre le Cancer - Institut Claudius Regaud | Recruiting |
| Toulouse Cedex, France, 31052 | |
| Principal Investigator: Jean Pierre Delord, MD | |
| Sub-Investigator: Michel Rives, MD | |
| Sub-Investigator: Adil Benlyazid, MD | |
| Sub-Investigator: Jérome Sarini, MD | |
| CHRU de Toulouse - Hôpital Purpan | Recruiting |
| Toulouse Cedex 9, France, 31059 | |
| Sub-Investigator: Séverine Valmary, MD | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
| Principal Investigator: | Benjamin Lallemant, MD | Centre Hospitalier Universitaire de Nîmes |
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 |
| Study First Received: | April 14, 2010 |
| Last Updated: | March 26, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Committee for the Protection of Personnes |
Additional relevant MeSH terms:
|
Laryngeal Neoplasms Neoplasms Carcinoma Carcinoma, Squamous Cell Hypopharyngeal Neoplasms Mouth Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Squamous Cell Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Head and Neck Neoplasms Neoplasms by Site Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Mouth Diseases |
ClinicalTrials.gov processed this record on May 19, 2013