A phase II randomized trial, non comparative, evaluating chemotherapy associated cisplatin, 5-fluorouracil and docetaxel at adapted doses in patients with locally advanced squamous cell carcinoma

Groupe Oncologie Radiotherapie Tete Cou0 个研究点目标入组 105 人开始时间: 2024年3月15日最近更新: 2024年7月22日

适应症

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•Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, histologically proven (several ENT locations are authorized), lymphadenopathy without portal of entry, Tumor considered inoperable or for which surgery would be mutilating, Patient not previously treated for ORL cancer, Age > 18 years and < 75 years, PS 0 or 1 according to WHO, At least one measurable lesion according to RECIST 1.1 criteria, Patient able to receive TPF according to well-defined criteria, Estimated life expectancy greater than or equal to 3 months.

•Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma, Other existing serious medical pathologies, Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients, Planned concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin, Recent or planned yellow fever vaccination, Deficiency of dihydropyrimidine dehydrogenase (DPD) activity, 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 with surgery alone for head and neck cancer in the previous 3 years are eligible., Previous treatment of head and neck cancer by chemotherapy or radiotherapy (Patients treated by surgery alone for head and neck cancer in the previous 3 years are eligible)., Presence of distant metastasis., Participation in a therapeutic trial within 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

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