Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (APPROCHE ORL)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01104714 |
Recruitment Status
:
Completed
First Posted
: April 15, 2010
Last Update Posted
: March 26, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Carcinoma, Squamous Cell Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms Hypopharyngeal Neoplasms |
Study Type : | Observational |
Actual Enrollment : | 90 participants |
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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Group/Cohort |
---|
All patients
As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.
|
- %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
Biospecimen Retention: Samples With DNA

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, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104714
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 |
Principal Investigator: | Benjamin Lallemant, MD | Centre Hospitalier Universitaire de Nîmes |
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 ( EudraCT Number ) |
First Posted: | April 15, 2010 Key Record Dates |
Last Update Posted: | March 26, 2015 |
Last Verified: | March 2015 |
Additional relevant MeSH terms:
Neoplasms Carcinoma, Squamous Cell Laryngeal Neoplasms Oropharyngeal Neoplasms Mouth 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 Pharyngeal Neoplasms Pharyngeal Diseases Stomatognathic Diseases Mouth Diseases |