Carcinoma, Squamous CellAPPROCHE ORLNCT01104714
Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
An observational study of Carcinoma, Squamous Cell and Mouth Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 14 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms
- How many people
- 90 participants
- Where
- 14 sitesFrance
- Study dates
- Apr 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- severe medullary hypoplasia
- severe autoimmune disease
- psychosis or senility
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CH d'Alès
Alès, 30103
CHU de Bordeaux - Groupe Hospitalier Saint-André
Bordeaux, 33075
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
CHU de Grenoble
Grenoble, 38043
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, 59020
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
Centre Regional de Lutte Contre le Cancer - Val d'Aurelle - Paul Lamarque
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
Centre de Lutte Contre le Cancer - Institut Claudius Regaud
Toulouse, 31052
Pharmacologie Clinique, expérim. des anticancéreux, CLCC Claudius Regaud
Toulouse, 31052
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
CHRU de Toulouse - Hôpital Larrey
Toulouse, 31059
CHRU de Toulouse - Hôpital Purpan
Toulouse, 31059
About this study
Official title: Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
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.
- Conditions
- Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms
- Medical subject headings
- Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | As the trial progresses, patients will be classified as either chemotherapy responders or non-responders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
%change in tumor volume before and after chemotherapy (baseline versus 62 days)
Tumor volume is calculated according to Labadie et al 2000
Measured: 62 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Lallemant, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104714
- Sponsor's protocol ID
- LOCAL/2008/BL-01
- Other IDs
- 2008-006874-14, 2008
- Acronym
- APPROCHE ORL
- Status last verified
- Mar 2015
- First submitted
- 14 Apr 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10696014
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
- ClinicalTrials.gov ID
- NCT01104714
- Acronym / sponsor ID
- APPROCHE ORL / LOCAL/2008/BL-01
- Conditions
- Carcinoma, Squamous Cell, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –As the trial progresses, patients will be classified as either chemotherapy responders or non-responders. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
%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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Background: PubMed 10696014Labadie 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.
Related trials for Carcinoma, Squamous Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Lallemant, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Squamous Cell and Mouth Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
%change in tumor volume before and after chemotherapy (baseline versus 62 days) (time frame: 62 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01104714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.