Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
NCT ID: NCT05611515
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
108 participants
OBSERVATIONAL
2022-06-17
2026-12-31
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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TORS
Patients operated by Trans-oral Robotic Surgery (TORS)
TORS
* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)
TLM
Patients operated by Trans-oral Laser Microsurgery (TLM)
TORS
* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)
IMRT
Patients treated by Intensity Modulated Radiation Therapy (IMRT)
TORS
* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)
Interventions
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TORS
* Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
* Arm 2: Trans-oral Laser Microsurgery (TLM)
* Arm 3: Trans-oral Robotic Surgery (TORS)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire UCLouvain Namur
OTHER
Responsible Party
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Professor Maximilien Gourdin
Professor
Locations
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CHU UCL Namur
Yvoir, Namur, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Hassid S, Krug B, Deheneffe S, Daisne JF, Delahaut G, Lawson G, Crott R, Van der Vorst S. Treatment of supraglottic squamous cell carcinoma with advanced technologies: observational prospective evaluation of oncological outcomes, functional outcomes, quality of life and cost-effectiveness (SUPRA-QoL). BMC Cancer. 2023 Jun 1;23(1):493. doi: 10.1186/s12885-023-10953-9.
Other Identifiers
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B0392022000044
Identifier Type: -
Identifier Source: org_study_id
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