Clinical trial · Observational
Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
Pharmacogenetic and Pharmacokinetic Aspects of the Response to Chemotherapy Induction Using Docetaxel, Cisplatin and 5-Fluorouracile (TPF)in ORL Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hypopharyngeal Neoplasms | Hypopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Laryngeal Neoplasms | Laryngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
| Oropharyngeal Neoplasms | Oropharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- As the trial progresses, patients will be classified as either chemotherapy responders or non-responders.
Primary outcomes (1)
- measure
- %change in tumor volume before and after chemotherapy (baseline versus 62 days)
- timeFrame
- 62 days
- description
- Tumor volume is calculated according to Labadie et al 2000
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLabadie 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. PMID 10696014