Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (APPROCHE ORL)
This study has been completed.
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 25, 2015
Last verified: March 2015
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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
| Enrollment: | 90 |
| Study Start Date: | April 2010 |
| Study Completion Date: | July 2014 |
| Primary Completion Date: | July 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 (Adult, Senior) |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104714
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 25, 2015 |
| 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:
|
Neoplasms Carcinoma, Squamous Cell Laryngeal Neoplasms Mouth Neoplasms Oropharyngeal 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 Mouth Diseases Stomatognathic Diseases Pharyngeal Neoplasms Pharyngeal Diseases |
ClinicalTrials.gov processed this record on September 27, 2016