Actively Recruiting
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
Led by Centre Hospitalier Universitaire UCLouvain Namur · Updated on 2022-11-10
108
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of supraglottic squamous cell carcinoma confirmed by histology
- Cancer staged as cT1-T2 / cN0-N1 / M0 according to the 8th TNM classification
- Multidisciplinary tumor board decision following NCCN or European guidelines
- Diagnostic imaging (head and neck and pulmonary CT or PET/CT, with or without MRI) performed within 1 month before study inclusion
- Age 18 years or older and able to provide informed consent
- ECOG/WHO performance status of 2 or less
You will not qualify if you...
- Previous radiotherapy or chemotherapy treatment in the head and neck region
- History of head and neck cancer within the past 5 years
- Prior invasive cancer unless disease-free for at least 5 years, except non-melanoma skin cancer
- Non-supraglottic or unknown primary tumor site
- Clinical or radiological evidence of nodal extracapsular extension
- Significant trismus with maximum mouth opening 35 mm or less
- Pre-existing dysphagia unrelated to the cancer or biopsy
- Inability or unwillingness to complete quality of life questionnaires
- Serious medical conditions or contraindications for surgery or radiation
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU UCL Namur
Yvoir, Namur, Belgium, 5530
Actively Recruiting
Research Team
H
Hassid Samantha, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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