Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Trial Title: Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

NCT ID: NCT05611515

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

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell

Conditions: Keywords:
Transoral Robotic Surgery (TORS)
Transoral Laser Microsurgery (TLM)
Intensity Modulated Radiation Therapy (IMRT)
Early Squamous Cell Carcinoma
Supraglottic

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: TORS
Description: - Arm 1: Intensity-Modulated Radiation Therapy (IMRT) - Arm 2: Trans-oral Laser Microsurgery (TLM) - Arm 3: Trans-oral Robotic Surgery (TORS)
Arm group label: IMRT
Arm group label: TLM
Arm group label: TORS

Other name: TLM

Other name: IMRT

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).

Criteria for eligibility:

Study pop:
The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Diagnosis of SSCC (with histological confirmation) - cT1-T2 / cN0-N1/ M0 according to 8th TNM classification (UICC/AJCC) - WITH a Multidisciplinary Tumor Board decision according to the NCCN or European guidelines - Diagnostic imaging (Head and neck and pulmonary CT or PET/CT, +/- IRM if needed) realized within 1 month before the study inclusion - ≥ 18 years old and able to provide an informed consent - ECOG/WHO performance status ≤ 2 Exclusion Criteria: - - Previous radiotherapy +/- chemotherapy treatment of the head and neck region - Previous history of head and neck cancer within 5 years - Prior invasive malignant disease unless disease-free for at least 5 years or more, with exception of non-melanoma skin cancer - Non-supraglottic or unknown primary site - Clinical and radiological signs of nodal extracapsular extension - Significant trismus (maximum inter-incisal opening ≤ 35 mm) - Pre-existing dysphagia not related to the cancer or the biopsy (from neurological disorders for example) - Unable or unwilling to complete Quality of Life questionnaires - Serious medical comorbidities or contraindication for surgery and/or radiation - Pregnancy and lactation

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU UCL Namur

Address:
City: Yvoir
Zip: 5530
Country: Belgium

Status: Recruiting

Contact:
Last name: Hassid Dr Samantha, Doctor

Phone: 003281423782
Email: samantha.hassid@chuuclnamur.uclouvain.be

Start date: June 17, 2022

Completion date: December 2026

Lead sponsor:
Agency: Centre Hospitalier Universitaire UCLouvain Namur
Agency class: Other

Source: Centre Hospitalier Universitaire UCLouvain Namur

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05611515