Looking for volunteers
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
NCT05611515 · Centre Hospitalier Universitaire UCLouvain Namur · Updated 10 Nov 2022
- What is being tested
- TORS
- For
- Supraglottic Squamous Cell Carcinoma; Early Stage (T1-T2, N0-N1,M0)
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 108 people. The full rules are on the registry page.
- Where
- Belgium
- When
- Starts or started 17 June 2022, ends Dec 2026. Registered 10 Nov 2022.
- Results
- None posted yet.
In the researchers' words
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).
Sites
- CHU UCL NamurYvoir, Namur, Belgium