Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Feasibility in terms of toxicity related to radiation therapy
研究概览
简要总结
This is a prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.
详细描述
The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •WHO performance status ≤ 2
- •Histologically-proven of primary cancer disease
- •M1 stage with primary cancer site radically treated with complete response/resection or stable. No other site of disease in progression (a maximum of 3 lymph node sites of disease to treat)
- •Diameter ≤ 5 cm
- •Abdomen/pelvic site
- •Informed consent.
排除标准
- •Patients were required to have not brain metastases or bone metastases.
- •Patients with a life expectancy of >3 months.
- •Any serious disease contraindicated radiation therapy
- •Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Additionally, patients were excluded from the trial if they were receiving any systemic chemotherapy during radiotherapy, although hormonal therapy was allowed.
结局指标
主要结局
Feasibility in terms of toxicity related to radiation therapy
时间窗: 2 months
Evaluation of acute and late toxicity performed during and after radiation therapy
次要结局
- Tumour response to local radiation therapy (RECIST criteria)(2 months)
- Disease free survival in the oligometastatic patients(2 months)
- Quality of life questionnaire of treated patients(2 months)
- Overall survival in the oligometastatic patients(2 months)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas