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Clinical Trial Summary

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).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05611515
Study type Observational
Source Centre Hospitalier Universitaire Dinant Godinne - UCL Namur
Contact Hassid Samantha, Doctor
Phone 003281423782
Email samantha.hassid@chuuclnamur.uclouvain.be
Status Recruiting
Phase
Start date June 17, 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Completed NCT03357107 - Local Control After Robot-assisted Supraglottic Laryngectomy N/A
Recruiting NCT02984410 - Study Assessing The "Best of" Radiotherapy vs the "Best of" Surgery in Patients With Oropharyngeal Carcinoma N/A
Active, not recruiting NCT01819480 - Efficacy and Safety of TORS for SCCA N/A