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

Phase 1

Conditions: squamous cell carcinomas of the larynx or hypopharynx locally advance
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-513976-16-00

Lead Sponsor: Groupe Oncologie Radiotherapie Tete Cou

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

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
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;Main Objective: 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.;Secondary Objective: Overall survival, Locoregional control, Survival without recurrence, Distant metastases (incidence and survival), Survival without laryngeal or pharyngoesophageal dysfunction with dynamic swallowing videocopy or according to VHI/DHI (if videocopy is missing), Laryngeal preservation, Response rate to induction chemotherapy, Acute and late toxicity, Feasibility and morbidity of salvage surgery, Quality of laryngeal and pharyngoesophageal function

Secondary Outcome Measures