A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 22
- 主要终点
- Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
研究概览
简要总结
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
详细描述
PRIMARY OBJECTIVE:
I. To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).
SECONDARY OBJECTIVE:
I. To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).
TERTIARY/EXPLORATORY 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
- All
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients with biopsy proven invasive cancer
- •Clinically and radiographically node negative
- •No indication of metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Synchronous bilateral invasive cancer allowed
- •Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
- •Willingness to participate in the clinical trial and adhere to the study protocol
- •Individuals of all races, genders and ethnic groups are eligible for this trial
排除标准
- •Need for neoadjuvant chemotherapy
- •Inflammatory breast cancer (cT4)
- •Multicentric tumor
- •Prior ipsilateral breast or thoracic RT
- •Contraindication for baseline magnetic resonance imaging (MRI)
- •Contraindication for surgery
- •Distant metastatic disease
- •Other synchronous cancer (besides bilateral breast)
- •Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
- •Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
结局指标
主要结局
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
时间窗: For at least 36 months after WBI
Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
次要结局
- Physician reported cosmesis(At 36 months after WBI)
研究者
Bruce G Haffty
Professor and Chairman, Department of Radiation Oncology
Rutgers Cancer Institute of New Jersey