Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,018
- 试验地点
- 2
- 主要终点
- Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer.
PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.
详细描述
OBJECTIVES:
- To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer.
OUTLINE: This is a multicenter study.
Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
- Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
- Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.
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
- •No primary endocrine therapy as a replacement for surgery
- •No concurrent chemoradiotherapy
排除标准
- 未提供
研究组 & 干预措施
Arm I (control)
Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
干预措施: radiation therapy (Radiation)
Arm III
Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
时间窗: 5 years
次要结局
- Location of tumor relapse(5 years)
- Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years(5 years)
- Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment(5 years)
- Regional and distant metastases(5 years)
- Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments(5 years)
- Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years(10 years)