Standardization of Breast Radiotherapy: Trial B - A Randomized Comparison of Fractionation Regimens After Local Excision or Mastectomy in Women With Early Stage Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 63
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of radiation therapy following surgery in treating women who have early stage breast cancer.
详细描述
OBJECTIVES:
- Determine the benefits of radiotherapy schedules using fraction sizes larger than 2.0 Gy in terms of normal tissue responses, local-regional tumor control, quality of life, and economic consequences in women prescribed postoperative radiotherapy for early stage breast cancer.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, type of surgery (mastectomy vs local excision), and breast boost (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive radiotherapy 5 times a week for 5 weeks for a total dose of 50 Gy.
- Arm II: Patients receive radiotherapy 5 times a week for 3 weeks for a total dose of 40 Gy.
A breast boost is recommended in both arms for patients with microscopic evidence of invasive or in situ cancer at, or within 1 mm of, a resection margin. These patients receive radiotherapy for 5 fractions in 1 week for a total boost dose of 10 Gy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供