CISPLATIN for Squamous cell carcinoma of the larynx | Squamous cell carcinoma of the hypopharynx

Inclusion criteria

• {"criterion_text":"-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"}
• {"criterion_text":"-Patient not previously treated"}
• {"criterion_text":"-PS 0 or 1"}
• {"criterion_text":"-Tumor volume evaluable according to RECIST"}
• {"criterion_text":"-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

• {"criterion_text":"-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"}
• {"criterion_text":"-Tumor requiring immediate tracheotomy."}
• {"criterion_text":"-Tumor immediately accessible to partial surgery"}
• {"criterion_text":"-Tumor requiring circular hypopharyngectomy"}
• {"criterion_text":"-N3 lymph node lesion"}
• {"criterion_text":"-Patients with AST or ALT > 1.5 LNS associated with alkaline phosphatase > 2.5 x LNS will not be eligible for the trial"}
• {"criterion_text":"-Clinical alteration of hearing function"}

Primary endpoints

• {"endpoint_text":"-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","definition_or_measurement_approach":"Events considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment; causes of death will be specified."}

Secondary endpoints

• {"endpoint_text":"-Overall survival. Events are considered to be: death from any cause.","definition_or_measurement_approach":"Event: death from any cause."}
• {"endpoint_text":"-Survival without recurrence. Events are considered: death from any cause, local recurrence, lymph node recurrence, distant metastases","definition_or_measurement_approach":"Events: death from any cause, local recurrence, lymph node recurrence, distant metastases."}
• {"endpoint_text":"-Locoregional control. Events are considered: local recurrence, lymph node recurrence","definition_or_measurement_approach":"Events: local recurrence, lymph node recurrence."}
• {"endpoint_text":"-Metastasis-free survival and incidence of metastases","definition_or_measurement_approach":"Metastasis-free survival measured by time to metastasis; incidence of metastases recorded."}
• {"endpoint_text":"-Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy","definition_or_measurement_approach":"Assessment according to dynamic swallowing videoscopy."}
• {"endpoint_text":"-Laryngeal preservation. Total laryngectomy is considered an event","definition_or_measurement_approach":"Event: total laryngectomy."}
• {"endpoint_text":"-Response rate to induction chemotherapy","definition_or_measurement_approach":"Response rate assessed after induction chemotherapy (method not further specified)."}
• {"endpoint_text":"-Toxicity of the treatments under study. By distinguishing between acute and late toxicities","definition_or_measurement_approach":"Toxicity assessed distinguishing acute versus late toxicities (specific scales not specified)."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Evaluation of number of recurrences successfully treated by salvage surgery and description of operative outcomes."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Quality of laryngeal and pharyngoesophageal function evaluated by qualitative scales: voice, swallowing (including type of alimentation), and respiration at rest and on exertion; rehabilitation quality of laryngectomized patients analysed."}

France

Earliest CTIS Part Ii Submission Date

17-06-2024

Latest Decision Or Authorization Date

15-07-2024

Processing Time Days

28

Number Of Sites

24

Number Of Participants

256

Primary sponsor

Full Name

Groupe Oncologie Radiotherapie Tete Cou

Organisation Type

Patient organisation/association

Country Of Registered Address

France