CHU UCL Namur
Yvoir, Namur, 5530, Belgium
Location status: Recruiting
NCT Number: NCT05611515
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Yvoir, Namur, 5530, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: TLM, IMRT
Time frame: 1 year
Clinical Dysphagia QoL evaluation after treatment will be assessed using MD Anderson Dysphagia Index (MDADI). MDADI consists of 20 items pooled in 4 subscales: the global scale (1 item); the functional scale (5 items); the physical scale (8 items); and the emotional scale (6 items). All items are scored on a 5-point scale (1-5), where "1" corresponds to "total agreement" and "5" to "total disagreement." All except 2 items were scored such that higher scores indicated higher functioning. Responses on all domains were summed to calculate the total score (MDADI-T). The maximum score is 100, indicating high functioning, and the minimum score is 20, indicating poor functioning.
Time frame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months
QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire It is composed on five functional scales (physical, performance, cognitive, emotional and social), three symptoms scale (fatigue, pain, nausea and vomiting), a global health status/QoL scale and 6 simple items for assessment of symptoms or additional problems (dyspnea, loss of appetite, insomnia, financial difficulties, constipation and diarrhea). All of the scale and single item measures range in score from 0 to 100. Regarding functional and overall health status scales, higher scores relate to better quality of life; however, for the scales of symptoms, higher scores correspond to the higher presence of this symptom and, consequently, the worse quality of life.
Time frame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months
QoL will be evaluated with the validated European Organization for Research and Treatment of Cancer (EORTC) H&N43 questionnaire It comprises 43 questions about symptoms and side effects of treatment, social function, body image and sexuality. It incorporates 12 symptom scales (pain, swallowing, problems with teeth, dry month and sticky saliva, problems with senses, speech, body image, social eating, sexuality, problems with shoulder, skin problems and fear of progression) and 7 simple items (problems opening mouth, coughing, social contact, swelling in the neck, weight loss, problem with wound healing and neurological problems). All of the scales and the single item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems.
Time frame: 1 and 2 years
Overall survival (%)
Time frame: 1 and 2 years
Disease specific survival (%)
Time frame: 1 and 2 years
Disease-free survival (%)
Time frame: 1 and 2 years
Loco-regional recurrence rate (%)
Time frame: 1 and 2 years
Distant recurrence rate (%)
Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
Swallowing function by FEES evaluation (Fiberoptic Endoscopic Evaluation of Swallowing) objectively evaluated by the Penetration-aspiration Scale (PAS) The PAS is an 8-point scale that rates the degree of airway invasion. Score of 1 is normal, score between 2-5 represent laryngeal penetration and scores up to 6 indicate airway aspiration.
Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
Weight (Kilogrammes)
Time frame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
CTC-AE Score for early and late complication The Common Terminology Criteria for Adverse Events (CTC-AE) is a descriptive terminology which was published by the National Cancer Institute (NCI) as part of an ongoing effort to standardize adverse events (AE) reporting within oncology. AE are graded according to an ordinal scale where 1 represents asymptomatic or mild symptoms and 5 represents death from the AE. In between, 2 is moderate, 3 is severe, and 4 is life-threatening. E.g., with regard to dysphagia, the CTCAE uses the descriptive terminology listed in Table 1, columns 1 and 2. CTCAE dysphagia grades are based on symptoms, diet, and tube dependency. This scale will be filled in by the physician.
Time frame: 1 and 2 years
Naso-gastric Feeding tube and/or gastrostomy use (duration in days)
Time frame: 1 and 2 years
Tracheostomy use (duration in days)
Time frame: 1 and 2 years
Need of hospitalization (yes or no; if yes, duration in days)
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire UCLouvain Namur
Other
Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
Acronym: SUPRA-QoL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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