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Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

NCT05611515 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2022-11-10

No results posted yet for this study

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

PROCEDURE

TORS

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire UCLouvain Namur

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05611515 on ClinicalTrials.gov