Treatment of Supraglottic Squamous Cell Carcinoma With Advance Technologies: Observational Evaluation of Quality of Life, Oncological Outcomes, Functional Outcomes and Economical Resources
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- 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
结局指标
主要结局
Clinical Dysphagia QoL evaluation using MD Anderson Dysphagia Index (MDADI)
时间窗: 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.
次要结局
- Oncological outcomes(1 and 2 years)
- Functional Outcomes(1 and 2 years)
- 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)
研究者
Professor Maximilien Gourdin
Professor
Centre Hospitalier Universitaire UCLouvain Namur