Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies

NCT05611515 | Recruiting DMC

• 1 other identifier: B0392022000044
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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 (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).

Conditions

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

Keywords

Transoral Robotic Surgery (TORS); Transoral Laser Microsurgery (TLM); Intensity Modulated Radiation Therapy (IMRT); Early Squamous Cell Carcinoma; Supraglottic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire

  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

  baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months

• Oncological Outcomes

  1 and 2 years

• Oncological outcomes

  1 and 2 years

• Oncological Outcomes

  1 and 2 years

Study Arms (3)

TORS

Patients operated by Trans-oral Robotic Surgery (TORS)

Procedure: TORS

TLM

Patients operated by Trans-oral Laser Microsurgery (TLM)

Procedure: TORS

IMRT

Patients treated by Intensity Modulated Radiation Therapy (IMRT)

Procedure: TORS

Interventions

TORS PROCEDURE

* Arm 1: Intensity-Modulated Radiation Therapy (IMRT) * Arm 2: Trans-oral Laser Microsurgery (TLM) * Arm 3: Trans-oral Robotic Surgery (TORS)

Also known as: TLM, IMRT

IMRT; TLM; TORS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• ≥ 18 years old and able to provide an informed consent
• ECOG/WHO performance status ≤ 2

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire UCLouvain Namur: lead

Study Sites (1)

CHU UCL Namur

Yvoir, Namur, 5530, Belgium

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Central Study Contacts

Hassid Samantha, Doctor

CONTACT

003281423782; samantha.hassid@chuuclnamur.uclouvain.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: November 10, 2022
• Study Start: June 17, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

BE (1)