Comparing treatments for early supraglottic squamous cell carcinoma
Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
This study is testing three different treatment options for early supraglottic squamous cell carcinoma to see which one helps patients feel better and live healthier lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire UCLouvain Namur Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Yvoir, Namur) |
| Trial ID | NCT05611515 on ClinicalTrials.gov |
What this trial studies
This observational, prospective, multicentric clinical trial aims to compare three treatment approaches for early supraglottic squamous cell carcinoma (SSCC): radiotherapy with or without chemotherapy, transoral laser microsurgery (TLM), and transoral robotic surgery (TORS). The study will evaluate the efficacy of each treatment based on quality of life, oncological outcomes, functional outcomes, and economic resources. A total of 108 patients will be enrolled, with 36 patients in each treatment arm, and outcomes will be assessed using validated questionnaires and clinical measures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of early-stage supraglottic squamous cell carcinoma (cT1-T2, cN0-N1, M0).
Not a fit: Patients with a history of previous head and neck cancer or those with significant trismus or pre-existing dysphagia unrelated to cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for early SSCC, potentially improving patient outcomes and quality of life.
How similar studies have performed: Other studies have shown success with similar treatment approaches for head and neck cancers, indicating potential for positive outcomes in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yvoir, Namur
- CHU UCL Namur — Yvoir, Namur, Belgium (Recruiting)
Study contacts
- Study coordinator: Hassid Samantha, Doctor
- Email: samantha.hassid@chuuclnamur.uclouvain.be
- Phone: 003281423782
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.