Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TORS.
- Who it may be relevant to
- Registry conditions: Supraglottic Squamous Cell Carcinoma, Early Stage (T1-T2, N0-N1,M0). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
Overview
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).
Interventions
- Procedure TORS
* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) * Arm 2: Trans-oral Laser Microsurgery (TLM) * Arm 3: Trans-oral Robotic Surgery (TORS)
Primary outcome measures
- Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI) [Time frame: 1 year]
Secondary outcome measures (12)
- Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire [Time frame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months]
- Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) H&N43 questionnaire [Time frame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months]
- Oncological Outcomes [Time frame: 1 and 2 years]
- Oncological outcomes [Time frame: 1 and 2 years]
- Oncological Outcomes [Time frame: 1 and 2 years]
- Oncological Outcomes [Time frame: 1 and 2 years]
- Oncological Outcomes [Time frame: 1 and 2 years]
- Functional Outcomes [Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment]
- Functional Outcomes [Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment]
- Functional Outcomes [Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment]
- Functional Outcomes [Time frame: 1 and 2 years]
- Functional Outcomes [Time frame: 1 and 2 years]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Belgium · 1 center
- CHU UCL Namur — Yvoir
Publications
- 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. PMID 37264321
Identifiers
NCT: NCT05611515 · B0392022000044