Patient-Reported Outcomes and Cosmesis Following Five Fraction Whole Breast Irradiation With Simultaneous Integrated Boost
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Harvard Breast Cosmesis Scale Score
研究概览
简要总结
This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.
详细描述
The study population will consist of 50 participants with non-metastatic, early-stage invasive breast cancer or ductal carcinoma in situ (DCIS). Eligible patients will include those with a biopsy proven invasive breast cancer or DCIS, greater than or equal to 18 years of age, undergoing breast conserving surgery and adjuvant radiation therapy at UW Health with an indication for WBI with tumor bed boost. Selection need for boost and radiation treatment field design and pre-tx imaging are at the discretion of the treating provider.
Accrual will occur over 5 years at UW Health. Participants will complete 5 treatment visits and 7 study visits over the course of approximately 5.5 years. Research-related outcome measures - MD assessments (e.g., cosmesis) PROMs, and AEs -- will be assessed prior to treatment start, at the 6-week follow-up visit, as well as at 12-, 24-, 36-, 48- and 60-month follow-up visits. Study participation ends after completion of the 60-month follow-up visit.
Objective
• To assess two-year cosmetic outcomes in patients treated with ultra-short WBI with a SIB.
Secondary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ability to understand and the willingness to sign a written informed consent document
- •Histologically confirmed early stage (stage T1-T2) invasive carcinoma of the breast or DCIS
- •Breast conserving surgery with negative margins and negative nodes (surgical axillary staging not mandatory), stage N0 or Nx
- •Treatment plan should include breast conserving surgery and adjuvant whole breast irradiation (WBI) therapy delivered with 3D-CRT or IMRT techniques
- •Treatment plan includes breast tumor bed boost
- •Willingness to comply with all study procedures and be available for the duration of the study
排除标准
- •Mastectomy of ipsilateral breast
- •Lack of histologic diagnosis
- •Histologic involvement of the axillary or regional nodes or metastatic disease
- •Accelerated partial breast irradiation treatment plan
- •Previous history of non-breast malignancy diagnosed in the past 5 years except for basal or squamous cell cancer of the skin
- •Previous history of chest radiation therapy
- •Previous history of ipsilateral breast cancer
- •Concurrent cytotoxic chemotherapy
- •Active connective tissue disease including scleroderma
- •Inability or unwillingness to return for required follow up visit
研究组 & 干预措施
WBI with SIB
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Harvard Breast Cosmesis Scale Score
时间窗: up to 2 years post-treatment (treatment ends up to 5 weeks on study)
4-point scale where 1 is excellent, 2 is good, 3 is fair, and 4 is poor.
次要结局
- Change in BREAST-Q Score(baseline, 6 weeks post-RT, 12 months post-RT, 24 months post-RT, 60 months post-RT (treatment ends up to 5 weeks on study))
- Incidence of Acute Toxicities(up to 90 days post-RT (treatment ends up to 5 weeks on study))
- Incidence of Late Toxicities(up to 60 months on study)
- Ipsilateral Breast Tumor Recurrence-Free Survival(up to 60 months on study)
- Overall Survival (OS)(up to 60 months on study)