NCT05611515

Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 108 (estimated)
• Sponsor: Centre Hospitalier Universitaire UCLouvain Namur · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Supraglottic Squamous Cell Carcinoma
• Early Stage (T1-T2, N0-N1,M0)

Interventions

Type	Name	Description
PROCEDURE	TORS	* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) * Arm 2: Trans-oral Laser Microsurgery (TLM) * Arm 3: Trans-oral Robotic Surgery (TORS)

Timeline

• Start date: 2022-06-17
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2022-11-10
• Last updated: 2022-11-10

Locations

1 site across 1 country: Belgium