Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 8
- 主要终点
- Determination of which patients are best suited for each individual technique of partial breast irradiation
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
详细描述
OBJECTIVES:
- To determine the cosmetic outcome resulting from partial breast irradiation using two different techniques.
- To determine patient satisfaction with partial breast irradiation as it pertains to their overall treatment experience as measured by a questionnaire.
- To determine if there are patient factors that limit a patient's suitability to receive partial breast irradiation delivered by a particular technique.
- To evaluate wound healing and overall complication rate after partial breast irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
Determination of which patients are best suited for each individual technique of partial breast irradiation
时间窗: Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
时间窗: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
Wound healing and overall complication rate after partial breast irradiation
时间窗: 1 month after RT & Q3mos for one year
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
时间窗: 1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire
时间窗: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
次要结局
未报告次要终点