Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- In-breast tumor recurrence (IBTR)
研究概览
简要总结
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ
- •Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
- •Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
排除标准
- •Prior malignancy, breast or other if metastatic or with anticipated survival of < 5 years
- •Pregnant women
- •Immunocompromised
- •Poorly controlled insulin dependent diabetes
- •Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
- •Breast cancer that involves skin or chest wall
- •Multifocal or Multicentric breast cancer
- •Invasive lobular carcinoma
- •Diffuse microcalcifications on mammography
- •Invasive carcinoma with extensive intraductal component (EIC)
- •Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
- •Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
- •Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
- •Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
结局指标
主要结局
In-breast tumor recurrence (IBTR)
时间窗: 20 years
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029
次要结局
未报告次要终点