Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

Korábbi kezelés

• 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).
• Concomitant anticancer treatment
• Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg / day of methylprednisolone or equivalent
• Intended concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin

Más betegség

• Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
• 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.
• Other existing serious medical pathologies (non-exhaustive list):
  • Uncontrolled cardiac pathology despite adequate treatment
  • Myocardial infarction in the 6 months preceding randomization
  • Neurological or psychiatric history such as dementia, convulsions
  • Active infection
  • Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer, and history of surgeries affecting absorption
  • Obstructive pulmonary disease requiring hospitalization in the year preceding randomization
  • Uncontrolled type II diabetes or other corticosteroid contraindications.
  • Moderate or severe eczema
• Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients.

Életkor

• 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.

Egyéb

• Vaccination against recent or planned yellow fever
• Known deficiency in dihydropyrimidine dehydrogenase (DPD) or determined by the determination of uricemia.
• Presence of distant metastasis.
• Participation in a therapeutic trial in the 30 days preceding randomization
• 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
• Persons deprived of their liberty, under guardianship or curatorship

• 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:
  • Technically impossible resection: fixation / invasion of the tumor at the base of the skull or at the cervical vertebrae, nasopharynx involved, lymph nodes
  • Medical selection based on low surgical curability. This category includes all T3-T4 and all N2-N3 (AJCC 8th edition, June 2018)
  • Medical selection based on an organ preservation strategy
• 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:
  • Adequate hematological function: neutrophils ³ 1.5 x 109 / l, platelets *100 x 109 / l, hemoglobin 10 g / dl (or 6.2 mmol / l)
  • Adequate renal function: calculated creatinine clearance (Cockroft \& Gault) or measured ³ 60 ml / min.
  • Adequate liver function: normal total bilirubin; ASAT and ALAT less than or equal to 1.5 ´ LNS; PAL less than or equal to 2.5 X LNS
  • Grade <2 peripheral neuropathy according to NCI CTCAE v5.0
  • No clinical impairment of hearing function
  • For patients aged 71 to 74, PS at 0 and considered non-geriatrically fragile (G8 questionnaire and multidimensional assessments proposed by the GERICO group (ADL, MMSE, GDS scale, nutrition, motor skills and balance, geographic and personal situation and assessments) thymic))
• 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)