Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies (SUPRA-QoL)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Supraglottic Squamous Cell Carcinoma; Early Stage (T1-T2, N0-N1,M0)
• Intervention / Treatment: Procedure: TORS

• Study Type: Observational
• Enrollment (Anticipated): 108

Contacts and Locations

• Study Contact: Name: Hassid Samantha, Doctor; Phone Number: 003281423782; Email: samantha.hassid@chuuclnamur.uclouvain.be

Study Locations

• Belgium
  • Namur
    • Yvoir, Namur, Belgium, 5530
      • Recruiting
      • CHU UCL Namur
      • Contact: Hassid Dr Samantha, Doctor; Phone Number: 003281423782; Email: samantha.hassid@chuuclnamur.uclouvain.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TORS; Patients operated by Trans-oral Robotic Surgery (TORS)	Procedure: TORS; Arm 1: Intensity-Modulated Radiation Therapy (IMRT); Arm 2: Trans-oral Laser Microsurgery (TLM); Arm 3: Trans-oral Robotic Surgery (TORS); Other Names: IMRT; TLM
TLM; Patients operated by Trans-oral Laser Microsurgery (TLM)	Procedure: TORS; Arm 1: Intensity-Modulated Radiation Therapy (IMRT); Arm 2: Trans-oral Laser Microsurgery (TLM); Arm 3: Trans-oral Robotic Surgery (TORS); Other Names: IMRT; TLM
IMRT; Patients treated by Intensity Modulated Radiation Therapy (IMRT)	Procedure: TORS; Arm 1: Intensity-Modulated Radiation Therapy (IMRT); Arm 2: Trans-oral Laser Microsurgery (TLM); Arm 3: Trans-oral Robotic Surgery (TORS); Other Names: IMRT; TLM

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dinant Godinne - UCL Namur

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Transoral Robotic Surgery (TORS); Transoral Laser Microsurgery (TLM); Intensity Modulated Radiation Therapy (IMRT); Early Squamous Cell Carcinoma; Supraglottic
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: B0392022000044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No