Adjuvant Partial-breast Irradiation of Early-stage Breast Cancer Using Stereotactic Body Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- APBI vs. WBI - tolerance
研究概览
简要总结
The adjuvant radiotherapy (RT) of the early-stage breast cancer patients as local treatment aims to eliminate the potential microscopic residual disease in the surgery bed or satellites in its neighborhood. Nowadays accelerated partial breast irradiation (APBI) is recommended for highly selected patients. This prospective randomized study compares the targeted external beam APBI with commonly used accelerated whole-breast irradiation (WBI) in terms of feasibility, safety, tolerance, and cosmetic effects. It is designed as non-inferiority trial and its aim is to increase the level of evidence for establishment of external beam APBI in indicated patients into daily clinical practice.
详细描述
Early-stage breast cancer patients after partial mastectomy are screened for eligibility. The inclusion criteria are age ˃ 50 years, non-lobular carcinoma histology, size ≤ 2 cm, negative margins ≥ 2 mm, L0, ER-positive, HER-2 negative. Enrolled patients are equally randomized into two arms according to radiotherapeutic regiment - external beam APBI (5× 6 Gy) and accelerated whole breast irradiation with the boost (15× 2,67Gy + 5× 2Gy). The follow-up visits are planned at the end of RT and 1, 3, 6, 9, and 12 months after radiation, in the second year every 4 months and then every 6 months. Cosmetics results and toxicity are evaluated using questionnaires, CTCAE criteria, and photodocumentation of the irradiated chest. The main objective of presented study is to evaluate the feasibility, safety, tolerance, and cosmetic effects of SBRT irradiation to the surgery bed in five fractions. In addition to standard clinical examination and evaluation of acute and late side effects, patients together with clinicians and nurses will independently complete a questionnaire on the impact of irradiation on the cosmetic effect. The technique of targeted external beam APBI should demonstrate better feasibility and less toxicity than the standard regimen in the adjuvant setting in treating early-stage breast cancer patients. Consequently, the presented study should increase the level of evidence for RT-indicated patients to the establishment of external APBI into daily clinical practice.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥50 years
- •Karnofsky index > 70
- •Partial mastectomy (breast-conserving surgery)
- •DCIS G1/2 ≤ 2.5 cm with negative margins (≥ 3 mm) or invasive (non-lobular) luminal-like HER2 negative carcinoma ≤ 2 cm with negative margins (≥ 2 mm) without LVI
- •In the case of invasive carcinoma, performing of axillary dissection (≥6 negative lymph nodes) or negative sentinel node biopsy
排除标准
- •Prior to other chest or breast surgery (including breast reconstruction), the absence of surgical clips in the tumor bed
- •Prior ipsilateral chest or breast radiotherapy
- •Neoadjuvant systemic therapy
- •Adjuvant chemotherapy
- •Multifocal or multicentric involvement
- •BRCA 1 or 2 mutations or known mutations in other high penetrance genes
- •Any systemic illness (collagen vascular diseases) or unstable medical condition that might pose additional risks for the performance of radiotherapy including claustrophobia or jactation
- •Any other factors that, in the opinion of the site investigators, would interfere with adherence to study requirements
- •Pregnancy or breastfeeding
- •Inability or unwillingness of the subject to sign written informed consent
结局指标
主要结局
APBI vs. WBI - tolerance
时间窗: 44 months
Comparison of tolerance of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.
APBI - feasibility
时间窗: 44 months
Evaluation of feasibility of the APBI regimen based on the proportion of patients who completed radiation in a total of 10 days and the proportion of patients who were irradiated exactly according to technical guidelines.
APBI vs. WBI - toxicity
时间窗: 44 months
Comparison of acute and late toxicity of the APBI of the early stage breast cancer with accelerated irradiation regimen.
APBI vs. WBI - cosmetic effects
时间窗: 44 months
Comparison of cosmetic effects of the APBI of the early stage breast cancer with accelerated irradiation regimen. Cosmetic effects independently evaluated by patient, physician, and nurse scored using Harvard scale (4-point Likert scale). The scale contains 4 values - nearly identical as untreated (the best outcome), slightly different, clearly different, seriously distorted (the worst outcome)
APBI vs. WBI - safety
时间窗: 44 months
Comparison of safety of the APBI of the early stage breast cancer with accelerated irradiation regimen. The toxicity was evaluated by CTCAE criteria (Common Terminology Criteria for Adverse Events). The outcome to define the tolerance a safety was CTCAE grade II or greater skin toxicity.
次要结局
- Quality of life C30(44 months)
- Quality of life BR45(44 months)
- Effectivity(44 months)