Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,324
- 试验地点
- 176
- 主要终点
- Progression free survival
研究概览
简要总结
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.
详细描述
Control Arm:
Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy.
or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy.
or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy.
Experimental Arm:
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
- •Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
- •Indication to adjuvant radiotherapy including boost radiotherapy
- •Clearly identified primary tumor region preferably by radiopaque clips
- •Primary wound healing after breast conserving therapy without signs of infection
- •Age ≥ 18 years
- •ECOG ≤ 2 Performance Status
- •Written informed consent
- •Compliance regarding treatment appointments and toxicity
- •Linguistic and cognitive ability to understand the questionnaires
排除标准
- •Patients operated by mastectomy
- •No indication for boost radiation (e.g. status after IORT)
- •double sided breast cancer
- •Resection margins positive for disease or insufficient identification of the boost volume
- •Indication for radiotherapy of the regional lymph nodes
- •History of prior breast or thoracic radiotherapy
- •Extended postoperative seroma at the beginning of radiotherapy
- •Previously administered radiotherapy not allowing the required dose
- •Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
- •treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
- •Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
研究组 & 干预措施
Hypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
干预措施: Hypofractionation with SIB (Radiation)
Standard radiation
Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or
Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or
Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
干预措施: Standard Radiation (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 3 to 6 years
any local or regional recurrence or distant metastasis or death
次要结局
- Overall survival(3 to 6 years)
- Cosmetic results (NCI-CTCAE)(1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months)
- Safety and side effects (Number of Patients with Adverse Events)(3 to 6 years)
- Time to occurence of local recurrence(3 to 6 years)
- Acute and chronic toxicity (NCI-CTCAE)(1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months)
研究者
Juergen Dunst, Prof.
Juergen Dunst, Prof.
University Hospital Schleswig-Holstein