Clinical Trial to Assess the Efficacy and Safety of Ultra_HYPofractionated RadiotHerapy in Women With BrEast CaNcer Receiving Regional Nodal Radiation vs Nodal Moderate Hypofractionated Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Locoregional recurrence (LRR)
研究概览
简要总结
The reduction in the number of fractions in radiotherapy is especially attractive in several senses, and even more so considering breast cancer, which has a high incidence and generally favorable prognosis. Thus, as a reference Institution, the investigators intend to start the treatment of selected patients with a radiotherapy scheme of 26 Gy / 5 fractions in one week, in a controlled manner, through this project.The investigators consider the moment extremely propitious to start the study, as in addition to having the first publication of a large randomized study, proving the effectiveness and safety of the strategy, the investigators will be able to benefit more patients and the health system itself by minimizing the daily visits of these patients at the hospital.
详细描述
This is a prospective, interventional, exploratory, controlled, randomized study in a 1:1 ratio, to be carried out in a single center, and seeks to evaluate the safety and efficacy of hypofractionated irradiation in women with breast cancer who receive nodal irradiation regional.
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
- •Information to the patient and signed informed consent;
- •Women aged ≥18 years;
- •Breast conserving surgery;
- •Invasive adenocarcinoma (except classic invasive lobular carcinoma);
- •TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
- •Eastern Cooperative Oncology Group (ECOG) 0 -1;
- •Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
- •No previous breast or mediastinal radiotherapy;
- •No hematogenous metastases;
- •Ability to carry out long-term follow-up;
排除标准
- •Previous local irradiation;
- •Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
- •Histology of metaplastic carcinoma;
- •History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
- •Diagnosis of autoimmune and connective tissue diseases;
- •Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
- •Indication of internal breast irradiation.
结局指标
主要结局
Locoregional recurrence (LRR)
时间窗: 10 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
次要结局
- Overall survival(10 years)
- Disease-free survival(10 years)
- Early and late adverse effects in normal tissues(10 years)
- Late adverse effects(10 years)
- Locoregional control(10 years)
- Acute toxicity rate(10 years)
- Measurement Satisfaction of Body Image of the participants(Baseline and 3 months, 6 months, 12 months after radiotherapy and 2 years, 10 years after treatment end)
- Evaluation of quality of life change by European Organization for Research and Treatment of Cancer Breast-Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)(Baseline and 3 months, 6 months, 12 months, 2 years, 10 years after treatment end)
研究者
Eduardo Barbieri
Principal Investigator
Instituto Brasileiro de Controle do Cancer