Phase III trial of laryngeal preservation comparating Induction chemotherapy with cisplatin, 5-fluorouracil and docetaxel (TPF) followed by radiotherapy and concomitant administration of radiotherapy with cisplatin (SALTORL).

Groupe Oncologie Radiotherapie Tete Cou0 个研究点目标入组 256 人开始时间: 2024年5月30日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Squamous cell carcinoma of the larynx or hypopharynx (excluding the retro-cricoarytenoid region and the posterior wall), histologically proven, locally advanced requiring total (pharyngo)-laryngectomy provided that the latter is feasible straight away and does not require circular hypopharyngectomy: -T2 not accessible to supra-cricoid partial laryngectomy or not, -T3 without massive infiltration of the endolarynx by a transglottic lesion, -N0 to N2c -Without distant metastasis -Without associated or previous cancer, Patient not previously treated, PS 0 or 1, Tumor volume evaluable according to RECIST, Absence of distant metastasis, confirmed by chest CT, abdominal ultrasound (or CT) in the event of abnormal liver function, and bone scintigraphy in the event of local symptoms.

•Transglottic T3 with massive infiltration of the hemilarynx or T4 with massive cartilaginous lysis or tumor of the retrocricoarytenoid region or the posterior hypopharyngeal wall, Tumor requiring immediate tracheotomy., Tumor immediately accessible to partial surgery, Tumor requiring circular hypopharyngectomy, N3 lymph node lesion, Patients with AST or ALT > 1.5 LNS associated with alkaline phosphatase > 2.5 x LNS will not be eligible for the trial, Clinical alteration of hearing function

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