Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies (SUPRA-QoL)

Centre Hospitalier Universitaire UCLouvain Namur

Status: Enrolling

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

Treatments: Procedure: TORS

Study type: Observational

Funder types: Other

Identifiers

NCT05611515

B0392022000044

Details and patient eligibility

About

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).

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

108 participants in 3 patient groups

TORS

Description:

Patients operated by Trans-oral Robotic Surgery (TORS)

Treatment:

Procedure: TORS

TLM

Description:

Patients operated by Trans-oral Laser Microsurgery (TLM)

Treatment:

Procedure: TORS

IMRT

Description:

Patients treated by Intensity Modulated Radiation Therapy (IMRT)

Treatment:

Procedure: TORS