Phase III trial of laryngeal preservation comparating chemotherapy followed by radiotherapy to chemotherapy administrated during radiotherapy.

Phase 3

Active, not recruiting

• Conditions: squamous cell carcinomas of the larynx or hypopharynx locally advance

• Registration Number: 2024-513976-16-00
• Lead Sponsor: Groupe Oncologie Radiotherapie Tete Cou

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 256

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

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.

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ;Secondary Objective: ;Primary end point(s):
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

Secondary Outcome Measures

Name	Time	Method
Overall survival. Events are considered to be: death from any cause.		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		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		Locoregional control. Events are considered: local recurrence, lymph node recurrence
Metastasis-free survival and incidence of metastases		Metastasis-free survival and incidence of metastases
Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy		Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy
Laryngeal preservation. Total laryngectomy is considered an event		Laryngeal preservation. Total laryngectomy is considered an event
Response rate to induction chemotherapy		Response rate to induction chemotherapy
Toxicity of the treatments under study. By distinguishing between acute and late toxicities		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.		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.		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.

Trial Locations

Locations (24)

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris Cedex 15, France

Institut De Cancerologie De Lorraine; 🇫🇷 Vandoeuvre Les Nancy Cedex, France

University Hospital Of Clermont-Ferrand; 🇫🇷 Clermont Ferrand Cedex 1, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Oncopole Claudius Regaud; 🇫🇷 Toulouse Cedex 9, France

Institut Regional Du Cancer De Montpellier; 🇫🇷 Montpellier Cedex 5, France

Centre Francois Baclesse; 🇫🇷 Caen Cedex 5, France

Clinique Victor Hugo; 🇫🇷 Le Mans, France

Institut De Cancerologie De L Ouest; 🇫🇷 Saint-Herblain Cedex, France

Centre Hospitalier Universitaire De Nantes; 🇫🇷 Nantes, France

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Assistance Publique Hopitaux De Paris

🇫🇷Paris Cedex 15, France

Sarah KREPS

Site contact

0033156092502

sarah.kreps@egp.aphp.fr