Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

Study Overview
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Brief Summary
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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).

Official Title
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Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources

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

Intervention / Treatment
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* Procedure: TORS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TORS<br>Patients operated by Trans-oral Robotic Surgery (TORS) | Procedure: TORS<br>* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) Arm 2: Trans-oral Laser Microsurgery (TLM) Arm 3: Trans-oral Robotic Surgery (TORS)<br>* Other names: IMRT;|
| TLM<br>Patients operated by Trans-oral Laser Microsurgery (TLM) | Procedure: TORS<br>* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) Arm 2: Trans-oral Laser Microsurgery (TLM) Arm 3: Trans-oral Robotic Surgery (TORS)<br>* Other names: IMRT;|
| IMRT<br>Patients treated by Intensity Modulated Radiation Therapy (IMRT) | Procedure: TORS<br>* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) Arm 2: Trans-oral Laser Microsurgery (TLM) Arm 3: Trans-oral Robotic Surgery (TORS)<br>* Other names: IMRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI) | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire | 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. | 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 | 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. | baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months | 
| Oncological Outcomes | Overall survival (%) | 1 and 2 years | 
| Oncological outcomes | Disease specific survival (%) | 1 and 2 years | 
| Oncological Outcomes | Disease-free survival (%) | 1 and 2 years | 
| Oncological Outcomes | Loco-regional recurrence rate (%) | 1 and 2 years | 
| Oncological Outcomes | Distant recurrence rate (%) | 1 and 2 years | 
| Functional Outcomes | 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. | baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment | 
| Functional Outcomes | Weight (Kilogrammes) | baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment | 
| Functional Outcomes | 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. | baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment | 
| Functional Outcomes | Naso-gastric Feeding tube and/or gastrostomy use (duration in days) | 1 and 2 years | 
| Functional Outcomes | Tracheostomy use (duration in days) | 1 and 2 years | 
| Functional Outcomes | Need of hospitalization (yes or no; if yes, duration in days) | 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensity Modulated Radiation Therapy (IMRT), Early Squamous Cell Carcinoma, Transoral Robotic Surgery (TORS), Transoral Laser Microsurgery (TLM), Supraglottic