Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05611515

Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

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

Sex: All
Ages: 18 Years – N/A
Enrollment: 108
Sponsor: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Location: Belgium

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 ± chemotherapyArm 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 questionnairesOncological outcomesFunctional outcomesEconomical ResourcesThe 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).

Eligibility 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 guidelinesDiagnostic 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 consentECOG/WHO performance status ≤ 2Exclusion Criteria:- Previous radiotherapy +/- chemotherapy treatment of the head and neck regionPrevious history of head and neck cancer within 5 yearsPrior invasive malignant disease unless disease-free for at least 5 years or more, with exception of non-melanoma skin cancerNon-supraglottic or unknown primary siteClinical and radiological signs of nodal extracapsular extensionSignificant 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 questionnairesSerious medical comorbidities or contraindication for surgery and/or radiationPregnancy and lactation

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611515). StuddyBuddy aggregates publicly available trial information.