Non Elective Vulnerable Elderly Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Loco-regional control
研究概览
简要总结
To evaluate whether patients defined "non-fit for curative non-surgical radio-chemotherapy" and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.
详细描述
The current standard approach for head and neck malignancies cannot be considered the gold standard for elderly patients, except in carefully selected cases. Given the relevance of this population, scientific societies also suggest to propose prospective studies for this subset of frail patients (European Organization for Research and treatment of cancer (EORTC), European Society for Medical oncology (ESMO)). In addition, it is necessary to collect data on specific categories, which are as homogeneous as possible. Therefore, the purpose of this study is to evaluate efficacy and safety of a tailored RT approach administered with a curative intent in a subset of frails elderly patients not candidates neither to standard concurrent RT-CT / RT-cetuximab nor to palliative treatment/best supportive care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •locally advanced non-metastatic HNSCC patients older than 70 years
- •Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII.
- •patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care
- •Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor
- •Karnofsky performance status (KPS) ≥60/100
- •Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE
排除标准
- •Age less than 70 years
- •Staging exams done 45 days before the date of the beginning of the treatment
- •Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease
- •Gross total excision
- •All subsites concerned if N
- •Squamous cell neoplasms of the glottic larynx T1-T2 N
- •Unknown primary HPV negative or EBV positive.
- •Presence of distant metastases or sub-clavicular lymphadenopathies.
- •Previous surgery on T and/or N except diagnostic tonsillectomy.
- •3D-conformational radiotherapy technique
研究组 & 干预措施
Open: non elective irradiation
Patients within inclusion criteria will be enrolled in the experimental treatment: a radiation therapy addressed to non elective site of disease and with a simultaneous integrated boost
干预措施: Non elective radiotherapy (Radiation)
结局指标
主要结局
Loco-regional control
时间窗: 24 months after the start of treatment
clinical or radiological (RECIST 1.1) disease progression from end of treatment with tumor present, or to the date of salvage surgery of primary tumor with tumor present performed for clinical or radiological (RECIST 1.1) disease progression, whichever comes first.
次要结局
- Cause-specific mortality rates(within 3 months after start of treatment)
- progression free survival(12 and 24 months)
- overall survival(5 years)
- G8 role(6 and 12 months)
- rate of severe sub-acute or late toxicity(at 6 and 12 months after the completion of radiotherapy)
研究者
Elisa D'angelo
Medical Doctor, MD
Azienda Ospedaliero Universitaria Policlinico Modena