Supraglottic Squamous Cell CarcinomaSUPRA-QoLNCT05611515
Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
An observational study of Supraglottic Squamous Cell Carcinoma and Early Stage (T1-T2, N0-N1,M0), run by Centre Hospitalier Universitaire UCLouvain Namur at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraglottic Squamous Cell Carcinoma, Early Stage (T1-T2, N0-N1,M0)
- What is being tested?
- TORS
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.
Who may be able to join
- 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
Who cannot join
- - 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU UCL Namur
Yvoir, Namur, 5530
Hassid Dr Samantha, Doctor, 003281423782, samantha.hassid@chuuclnamur.uclouvain.be
About this study
Official title: 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)
Read more
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).
- Being tested
- TORS
- Keywords
- Transoral Robotic Surgery (TORS), Transoral Laser Microsurgery (TLM), Intensity Modulated Radiation Therapy (IMRT), Early Squamous Cell Carcinoma, Supraglottic
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORSProcedure or surgery
Also called TLM, IMRT
- Arm 1: Intensity-Modulated Radiation Therapy (IMRT)
- Arm 2: Trans-oral Laser Microsurgery (TLM)
- Arm 3: Trans-oral Robotic Surgery (TORS)
| Study group | Role | What they receive |
|---|---|---|
| TORS | Patients operated by Trans-oral Robotic Surgery (TORS) Receives: Procedure: TORS | |
| TLM | Patients operated by Trans-oral Laser Microsurgery (TLM) Receives: Procedure: TORS | |
| IMRT | Patients treated by Intensity Modulated Radiation Therapy (IMRT) Receives: Procedure: TORS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (13)
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.
Measured: 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.
Measured: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months
Oncological Outcomes
Overall survival (%)
Measured: 1 and 2 years
Oncological outcomes
Disease specific survival (%)
Measured: 1 and 2 years
Oncological Outcomes
Disease-free survival (%)
Measured: 1 and 2 years
Oncological Outcomes
Loco-regional recurrence rate (%)
Measured: 1 and 2 years
Oncological Outcomes
Distant recurrence rate (%)
Measured: 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.
Measured: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
Functional Outcomes
Weight (Kilogrammes)
Measured: 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.
Measured: 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)
Measured: 1 and 2 years
Functional Outcomes
Tracheostomy use (duration in days)
Measured: 1 and 2 years
Functional Outcomes
Need of hospitalization (yes or no; if yes, duration in days)
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start17 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supraglottic Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain Namur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Maximilien Gourdin, Centre Hospitalier Universitaire UCLouvain Namur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611515
- Sponsor's protocol ID
- B0392022000044
- Acronym
- SUPRA-QoL
- Status last verified
- Nov 2022
- First submitted
- 14 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37264321
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
- ClinicalTrials.gov ID
- NCT05611515
- Acronym / sponsor ID
- SUPRA-QoL / B0392022000044
- Keywords
- Transoral Robotic Surgery (TORS), Transoral Laser Microsurgery (TLM), Intensity Modulated Radiation Therapy (IMRT), Early Squamous Cell Carcinoma, Supraglottic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire UCLouvain NamurUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TORS | – | Procedure: TORSPatients operated by Trans-oral Robotic Surgery (TORS) |
| TLM | – | Procedure: TORSPatients operated by Trans-oral Laser Microsurgery (TLM) |
| IMRT | – | Procedure: TORSPatients treated by Intensity Modulated Radiation Therapy (IMRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.
Key inclusion criteria (6 listed)
- Diagnosis of SSCC (with histological confirmation)
- 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
Key exclusion criteria (10 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORSAlso: TLM, IMRT* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) * Arm 2: Trans-oral Laser Microsurgery (TLM) * Arm 3: Trans-oral Robotic Surgery (TORS) | Procedure or surgery | IMRT, TLM, TORS |
Primary outcome
Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI)
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.
13 secondary outcomes
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
Functional Outcomes
Time frame: 1 and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 37264321Hassid 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraglottic Squamous Cell Carcinoma and Early Stage (T1-T2, N0-N1,M0), run by Centre Hospitalier Universitaire UCLouvain Namur at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hassid Samantha, Doctor (003281423782, samantha.hassid@chuuclnamur.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.