ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Early and Intermediate Toxicity
研究概览
简要总结
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •A confirmed histological diagnosis of invasive breast carcinoma or DCIS
- •Age greater or equal to 50 years old
- •Life expectancy > 6 months
- •Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy
- •Pathologic tumor size less than or equal to 2 cm
- •Invasive ductal, mucinous, tubular or colloid histology
- •Estrogen receptor positive for invasive carcinoma.
- •Unifocal/unicentric disease
- •Negative surgical margins greater than or equal to 2 mm
- •Pathologic lymph node negative
- •No evidence of lymphovascular invasion
- •ECOG performance status of 0 or 1 (Appendix 1)
- •Informed consent signed.
排除标准
- •Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required)
- •Autoimmune disorder
- •Breast implants
- •Psychiatric or addictive disorder that would preclude attending follow-up
- •Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted)
- •Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign)
- •Lobular features on histology (pure or mixed) or sarcoma histology
- •Node positive on axillary dissection or in the sentinel lymph node biopsy;
- •Extensive in situ carcinoma (EIC)
- •Multicentric or multifocal disease
- •Paget's disease of the nipple
- •Distant metastases
- •Lumpectomy cavity not well visualized on AccuBoost imaging
- •Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm)
- •Breast separation with compression > 7cm.
- •Overlap of skin between orthogonal treatment axes.
研究组 & 干预措施
Radiation
AccuBoost APBI- 34.0 Gy in 10fx
干预措施: Accelerated partial breast irradiation (Radiation)
Extended Follow up
This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
干预措施: Extended Follow up (Other)
结局指标
主要结局
Early and Intermediate Toxicity
时间窗: 2 years
Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table.
次要结局
- Cosmetic Outcome(2 years)
研究者
Jaroslaw Hepel
principal investigator
Brown University