Status and phase
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About
The objective of this study is to evaluate the efficacity of the combination of cisplatin-5-FU and docetaxel in adapted doses in term of response to treatment without toxicity
.
Full description
After explaining the treatment modalities, having read and explained the information letter to them, patients who have signed the consent to participate in the trial and who meet the inclusion criteria will be enrolled and randomized in the trial .
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx, lymphadenopathy without front door
Inoperable tumor or tumor whose surgery would be multilating.
The non-operability criteria are:
Patient not previously treated for ORL cancer
Age > 18 and < 75 years
PS 0 or 1 according to WHO
At least one lesion measurable according to the RECIST 1.1 criteria
Patient who can receive TPF according to the following criteria:
Estimated life expectancy greater than or equal to 3 months
Weight loss of less than 10% during the 3 months before randomization
Patient understanding French and able to complete quality of life questionnaires
Patient having given written consent before any specific protocol procedure
Affiliation to a social security scheme or beneficiary of such a scheme
Women of childbearing potential and sexually active men agreeing to use effective contraceptive methods for the duration of treatment and at least 6 months after the last administration of study treatments
Patient agrees not to donate sperm for the duration of the treatment and at least 6 months after the last administration of the study treatments
Absence of deficiency in dihydropyrimidine dehydrogenase activity determined by uracilemia assay (Uracilemia < 16 ng/mL)
Exclusion criteria
Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
Vaccination against recent or planned yellow fever
Known deficiency in dihydropyrimidine dehydrogenase (DPD) or determined by the determination of uricemia.
History of other cancer except in situ cervical cancer or controlled basal cell carcinoma. Patients in remission from cancer treated more than 3 years ago are eligible. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible.
Previous treatment of an ORL cancer by chemotherapy or radiotherapy. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible).
Presence of distant metastasis.
Participation in a therapeutic trial in the 30 days preceding randomization
Concomitant anticancer treatment
Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg / day of methylprednisolone or equivalent
Other existing serious medical pathologies (non-exhaustive list):
Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients.
Intended concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin
Presence, upon selection, of psychological, family, social or geographic factors likely to influence the patient's compliance with the study and monitoring protocol.
Pregnant or lactating woman
Patient (male or female) of reproductive age who is unable or unwilling to take adequate contraceptive measures during treatment and up to 6 months after the last treatment is administered.
Persons deprived of their liberty, under guardianship or curatorship
Primary purpose
Allocation
Interventional model
Masking
105 participants in 2 patient groups
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Central trial contact
Martial BINDZI
Data sourced from clinicaltrials.gov
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