Effectiveness and Tolerability of Metastases-directed Radiotherapy in Addition to Standard Systemic Therapy in Patients With Oligometastatic Breast Cancer: A Randomized Controlled Multinational and Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 564
- 试验地点
- 28
- 主要终点
- First co-primary outcome measure is progression-free survival (PFS)
研究概览
简要总结
The prognosis for patients with metastatic breast cancer has improved continuously. Systemic therapies alone are not able to cure the disease permanently.
Investigators initiated this randomized controlled multinational and multicenter clinical trial to analyse the impact of a local metastases-directed radiotherapy in addition to standard systemic therapy in patients with oligometastatic breast cancer on progression-free survival and quality of life.
详细描述
Preferably ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions. Larger lesions or lesions with critical normal tissue involvement should be treated with three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) in moderate hypofractionated radiotherapy (depending on the size and location of the target volume and the decision of the radiooncologist). For critical organs in the target volume, standard fractionated radiotherapy can be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Metastasized breast cancer - up to 5 clinically manifest (new, progressive, persistent) metastases (a lymph node metastasis and a circumscribed local recurrence are each considered as one metastasis, i.e. also locoregional recurrent breast carcinomas with additional hematogenic metastasis possible)
- •maximum of 3 cerebral metastases known
- •indication for palliative drug therapy (endocrine therapy and/or chemotherapy and/or treatment with other substances) given according to guidelines (1st-line or further therapy lines, a special regime is not specified)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- •local radiation of all metastases possible
- •presentation of a written declaration of consent
- •patient ≥ 18 years
排除标准
- •Previous radiotherapy, if this interferes with treatment within the scope of the study
- •symptomatic metastases requiring local therapy of all metastases (e.g. pain radiation), a radiation indication (or other local therapy) for individual metastases is not a criterion for exclusion
- •known central nervous system (CNS) metastasis without extracerebral metastasis (in these cases, immediate local therapy is mandatory)
- •more than three known CNS metastases (no indication for purely local therapy of only the metastases, primary whole brain radiation is indicated)
- •multifocal metastasis in one organ with impossibility to comply with the dose constraints for this organ (e.g., no indication for local therapy of only the metastases, primary whole brain radiation is indicated) (e.g. in the liver)
- •exclusively regional lymph node metastasis without haematogenic metastases (in these cases local therapy is clearly indicated according to guidelines)
- •relevant comorbidity, if this results in restrictions for further therapy
- •Incapacity to contract or lack of informed consent
- •Pregnancy and lactation
结局指标
主要结局
First co-primary outcome measure is progression-free survival (PFS)
时间窗: at least 12 months after randomization
Co-primary progression-free survival (PFS) according to Response Evaluation Criteria In Solid Tumors (RECIST)
Second co-primary outcome measure is quality of life
时间窗: 12 weeks after randomization
Co-primary quality of life according to European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer patients with 30 items (QLQ-C30) sum score
次要结局
- Breast cancer-specific quality of life(quarterly up to 5 years)
- Feasibility (per-protocol within intention-to-treat)(12 weeks)
- Overall survival(at least 1, up to 5 years)
- Toxicity (number and degree of reported toxicities in both treatment arms)(0 to 5 years)
- Neoplasia-specific quality of life(quarterly up to 5 years)
- Patient satisfaction(12 weeks)
- Frequency of adverse events(0 to 5 years)