Clinical trial NCT05611515: Treatment of Early Supraglottic Squamous Cell Carcinoma With Advance Technologies
Official title: Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Centre Hospitalier Universitaire UCLouvain Namur
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population will include cT1-T2 /cN0-N1/M0 supraglottic squamous cell carcinoma.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI)
timeFrame: 1 year
Secondary outcomes:
measure: Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
timeFrame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months
measure: Quality of Life Measures with the validated European Organization for Research and Treatment of Cancer (EORTC) H&N43 questionnaire
timeFrame: baseline (before treatment), 3 - 6 - 9 - 12 - 18 - 24 months
measure: Oncological Outcomes
timeFrame: 1 and 2 years
measure: Oncological outcomes
timeFrame: 1 and 2 years
measure: Oncological Outcomes
timeFrame: 1 and 2 years
measure: Oncological Outcomes
timeFrame: 1 and 2 years
measure: Oncological Outcomes
timeFrame: 1 and 2 years
measure: Functional Outcomes
timeFrame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
measure: Functional Outcomes
timeFrame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
measure: Functional Outcomes
timeFrame: baseline (before treatment), 1 - 3 - 6 - 9 - 12 - 18 - 24 months after treatment
measure: Functional Outcomes
timeFrame: 1 and 2 years
measure: Functional Outcomes
timeFrame: 1 and 2 years
measure: Functional Outcomes
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU UCL Namur
state: Namur
Study officials:
References: