A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,004
- 试验地点
- 2
- 主要终点
- Time to recurrence
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 whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.
PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.
详细描述
OBJECTIVES:
Primary
- Estimate and compare local recurrence-free survival of women with ductal breast carcinoma in situ (DCIS) treated with breast-conserving surgery followed by whole breast irradiation with vs without a radiation tumor bed boost.
Secondary
- Compare relapse-free survival between the two arms.
- Compare overall survival.
- Compare acute and late toxicities.
- Compare cosmetic results and quality of life.
- Identify patients at risk for late toxicities using a biological test.
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 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ductal carcinoma in situ of the breast
- •No invasive component
- •No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done)
- •No local recurrence of a primary breast cancer
- •No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm
- •Has undergone bilateral mammography within 6 months before randomization
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 5 years
- •Not pregnant
- •Available for long-term follow up
- •No history of in situ carcinoma in the contralateral breast
- •No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No uncontrolled cardiac, renal, or pulmonary disease
- •No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma)
- •No HIV positivity
- •Affiliated with the social health system
- •No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo whole breast irradiation (WBI) once daily for 5 weeks (weekdays only).
干预措施: whole breast irradiation (Radiation)
Arm II
Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
干预措施: partial breast irradiation (Radiation)
Arm II
Patients undergo WBI as in arm I and a radiation tumor bed boost once daily for 8 days (weekdays only).
干预措施: whole breast irradiation (Radiation)
结局指标
主要结局
Time to recurrence
时间窗: up to 15 years of follow up
次要结局
未报告次要终点