NCT00103181已完成不适用
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,216
- 试验地点
- 773
- 主要终点
- In-breast tumor recurrence (IBTR)
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation following lumpectomy.
Secondary
- Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
- Compare the cosmetic result in patients treated with these regimens.
- Compare fatigue and treatment-related symptoms in patients treated with these regimens.
- Compare perceived convenience of care in patients treated with these regimens.
- Compare acute and late toxic effects of these regimens in these patients.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
In-breast tumor recurrence (IBTR)
时间窗: every 6 months for 5 years; annually thereafter for up to 10 years
次要结局
- Recurrence-free survival(time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years)
- Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms(measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment)
- Overall survival(time from randomization to death due to any cause assessed up to 15 years)
- Distant disease-free survival(time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years)
- Toxicity as assessed by adverse events during treatment(at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years)
研究者
研究点 (773)
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