Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers (NCT01104714) | Clinical Trial Compass
CompletedNot Applicable
Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
France90 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
%change in tumor volume before and after chemotherapy (baseline versus 62 days)