Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Recruiting now

Conditions studied: Supraglottic Squamous Cell Carcinoma, Early Stage (T1-T2, N0-N1,M0)

In brief

In this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with SSCC according to 3 arms of treatment: * Arm 1: Radiotherapy ± chemotherapy * Arm 2: Trans-oral Laser Microsurgery (TLM) * Arm 3: Trans-oral Robotic Surgery (TORS) The main goal is to evaluate the efficacy of each treatment with four classes of outcomes: * The quality of life (QoL) before and after each treatment option, using validated questionnaires * Oncological outcomes * Functional outcomes * Economical Resources The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma. The primary outcome is a Clinical Dysphagia QoL evaluation assessed by the MD Anderson Dysphagia questionnaire. Secondary outcomes include others QoL evaluation, oncological and functional measures and cost parameters. The sample size needs to reach 36 patients per arm (total 108).

Key facts

Study ID

NCT05611515

Run by

Centre Hospitalier Universitaire UCLouvain Namur

People needed

108

Starts

2022-06-17

Expected to finish

2026-12-01

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SSCC (with histological confirmation)
• cT1-T2 / cN0-N1/ M0 according to 8th TNM classification (UICC/AJCC)
• WITH a Multidisciplinary Tumor Board decision according to the NCCN or European guidelines
• Diagnostic imaging (Head and neck and pulmonary CT or PET/CT, +/- IRM if needed) realized within 1 month before the study inclusion
• ≥ 18 years old and able to provide an informed consent
• ECOG/WHO performance status ≤ 2

You may not qualify if…

• - Previous radiotherapy +/- chemotherapy treatment of the head and neck region
• Previous history of head and neck cancer within 5 years
• Prior invasive malignant disease unless disease-free for at least 5 years or more, with exception of non-melanoma skin cancer
• Non-supraglottic or unknown primary site
• Clinical and radiological signs of nodal extracapsular extension
• Significant trismus (maximum inter-incisal opening ≤ 35 mm)
• Pre-existing dysphagia not related to the cancer or the biopsy (from neurological disorders for example)
• Unable or unwilling to complete Quality of Life questionnaires
• Serious medical comorbidities or contraindication for surgery and/or radiation
• Pregnancy and lactation

Where it is running

• CHU UCL Namur — Yvoir, Namur, Belgium (enrolling)

Full record on ClinicalTrials.gov

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