Randomized Study on Postmenopausal Women With Early Stage Breast Cancer: Adjuvant Hypofractionated Whole Breast Irradiation (WBI) Versus Accelerated Partial Breast Irradiation (APBI)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Toxicity will be measured with CTCAE v.4.0
研究概览
简要总结
Selected patients with early stage breast cancer undergone conservative surgery were randomized in two arms: Hypofractionated Whole Breast Irradiation versus Accelerated Partial Breast Irradiation.
详细描述
Patients treated with Hypofractionated Whole Breast Irradiation (WBI) received SIB irradiation of the whole breast and surgical bed at two different dose levels. Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
Accelerated Partial Breast Irradiation (APBI) using external intensity -modulated radiotherapy (VMAT RA) was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •55< Age <70
- •Tumor size ≤ 2 cm
- •pN0 (SN biopsy or ALND)
- •ER/PgR positive
- •Margins > 5 mm (either at initial surgery or at re-excision)
- •Clips placed in the surgical bed (minimum of 4 clips)
- •Unicentric only
- •No lymphovascular invasion
- •Any grade
- •No extensive intraductal component (>25%)
- •Written informed consent
排除标准
- •Prior thoracic radiation therapy
- •Oncoplastic surgery / No clips in the surgical bed
- •Multicentric cancer
- •Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae
研究组 & 干预措施
Hypofractionated WBI
Patients treated with hypofractionated Whole Breast Irradiation received Simultaneous Integrated Boost irradiation of the whole breast and surgical bed at two different dose levels using external intensity - modulated radiotherapy (VMAT RA).
干预措施: Hypofractionated WBI (Radiation)
Accelerated Partial Breast Irradiation
Patients treated with Accelerated Partial Breast Irradiation received the irradiation on surgical bed using external intensity - modulated radiotherapy (VMAT RA).
干预措施: Accelerated Partial Breast Irradiation (Radiation)
结局指标
主要结局
Toxicity will be measured with CTCAE v.4.0
时间窗: ten years
Cosmesis will be measured with Harvard scale
时间窗: ten years
次要结局
- Rate of Local Control(ten years)
- Quality of Life Questionnaire(ten years)
- Disease Free Survival(ten years)
- Overall Survival(ten years)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas