Clinical Trial, Randomized, Open Label, With an Active Comparator to Assess the Efficacy and Safety of Using Accelerated Partial Irradiation Versus Standard or Hypofractionated Irradiation of the Entire Breast in Patients With Initial Breast Cancer After Conservative Surgery
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
- Rate of local recurrence
研究概览
简要总结
Radiotherapy has been confirmed as an important treatment breast-conserving surgery reducing the risk of any recurrence of breast cancer and breast cancer-related mortality in patients with early breast cancer.
There are no comparative data on the ideal radiotherapy treatment regimen for patients with early stage breast cancer who underwent conservative surgery in the Brazilian population.
详细描述
The investigators propose a prospective, randomized, pilot study, with active control, to evaluate the viability and safety of accelerated partial breast irradiation, in 5 fractions, comparing with the radiotherapy regimens of the whole breast in 15 and 5 fractions, in patients with breast cancer, in initial stage, who underwent conservative surgery.
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
- 50 Years 至 90 Years（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 ≥50 years
- •Breast conserving surgery
- •Pathologic tumor size < 3 cm (maximum microscopic diameter of the invasive component)
- •Invasive adenocarcinoma (except classic invasive lobular carcinoma)
- •Unifocal disease
- •Histopathologic grades I or II
- •Eastern Cooperative Oncology Group (ECOG) 0-1
- •Lymphovascular invasion absent
- •Negative axillary lymph nodes
- •Minimum microscopic margins of non-cancerous tissue of 2mm (excluding deep margin when in deep fascia)
- •No prior breast or mediastinal radiotherapy
- •No hematogenous metastases
排除标准
- •Previous malignancy (except non-melanomatous skin cancer)
- •Mastectomy
- •Classical-Type Invasive Lobular Carcinoma
- •Neoadjuvant chemotherapy
- •Human Epidermal growth factor Receptor-type 2 positive (HER2+)
- •Triple-negative breast cancers
- •Intravascular lymphoma present
- •Contraindications to radiotherapy.
- •No geographical, social or psychologic reasons that would prevent study follow
结局指标
主要结局
Rate of local recurrence
时间窗: 5 years
To estimate and compare the rate of local recurrence between the experimental and control arms.
次要结局
- Acute toxicity rate(5 years)
- Medico-economic study(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
- Time to occurrence of distant metastases(5 years)
- Overall survival(5 years)
- Health-related Quality of Life(Baseline and 3 months, 6 months, 12 months, 2 years, 5 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, 5 years after treatment end)
- Late adverse effects(5 years)
- Early and late adverse effects in normal tissues(5 years)
- Disease-free survival(5 years)
- Fatigue Questionnaire (Functional Assessment of Cancer Therapy-Fatigue - FACT-F)(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
- Measurement Satisfaction of Body Image of the participants(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
- Changes in anxiety and depression(Baseline and 3 months, 6 months, 12 months, 2 years, 5 years after treatment end)
研究者
Eduardo Barbieri
Principal Investigator
Instituto Brasileiro de Controle do Cancer