2024-513976-16-00招募中3 期
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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 24
- 主要终点
- Survival with preservation of laryngeal and pharyngoesophageal function. The following events are considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment. The causes of death will be specified
研究概览
简要总结
Compare survival without laryngeal or pharyngoesophageal dysfunction, obtained by triple therapy (TPF) followed by external radiotherapy or by the concomitant combination of external radiotherapy and Cisplatin.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Survival with preservation of laryngeal and pharyngoesophageal function. The following events are considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment. The causes of death will be specified
Survival with preservation of laryngeal and pharyngoesophageal function. The following events are considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment. The causes of death will be specified
次要结局
- Overall survival. Events are considered to be: death from any cause.
- Survival without recurrence. Events are considered: death from any cause, local recurrence, lymph node recurrence, distant metastases
- Locoregional control. Events are considered: local recurrence, lymph node recurrence
- Metastasis-free survival and incidence of metastases
- Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy
- Laryngeal preservation. Total laryngectomy is considered an event
- Response rate to induction chemotherapy
- Toxicity of the treatments under study. By distinguishing between acute and late toxicities
- Feasibility and morbidity of salvage surgery: evaluation of the number of recurrences that could be successfully treated by salvage surgery and description of the operative consequences.
- Qualité de la fonction laryngée et pharyngo-oesophagienne. Seront évaluées par échelle qualitative : la voix, la déglutition (y compris le type d’alimentation) et la respiration au repos et à l’effort. La qualité de la réhabilitation des patients laryngectomisés sera également analysée.
研究者
Yoann POINTREAU
Scientific
Groupe Oncologie Radiotherapie Tete Cou
研究点 (24)
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