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 Cou24 sites in 1 country256 target enrollmentJuly 15, 2024

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Groupe Oncologie Radiotherapie Tete Cou
Enrollment: 256
Locations: 24
Primary Endpoint: 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
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

euclinicaltrials.eu

Start Date

July 15, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Responsible Party

Principal Investigator

Yoann POINTREAU

Scientific

Groupe Oncologie Radiotherapie Tete Cou

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.