Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI)
研究概览
简要总结
This is a pilot study to determine if partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy in patients screened with MRI provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3D-CRT to the whole breast.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0 or I breast carcinoma
- •40 years or older
- •Post menopausal
- •Lumpectomy with clear margins (>2mm)
- •Patients with invasive disease must have undergone an axillary staging by axillary dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy
- •Gross disease must be unifocal with pathological tumor size 2cm or less
- •Target lumpectomy cavity must be clearly marked with surgical clips (the target lumpectomy cavity/whole breast reference volume must be <=30% based on the postoperative imaging)
- •Bilateral MRI of the breasts within previous 6 months of radiation therapy (RT) planning
- •If patient is eligible based on postoperative imaging, partial breast irradiation (PBI) is judged to be technically deliverable
- •Patients with a history of malignancies are eligible if they have stable disease as determined by their attending oncologist
- •Patient must have signed the consent form
排除标准
- •Men are not eligible
- •Patients with Stage II, II, or IV breast cancer
- •Pre- or peri-menopausal patients
- •Patients with positive lymph nodes
- •Patients with suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign
- •Patients with multifocal, multicentric, or bilateral breast cancer
- •Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation
- •Patients with a history of breast cancer
- •Clear delineation of the extent of the target lumpectomy cavity is not possible
- •Breast implants (patients who have had implants removed are eligible)
- •Prior breast or thoracic RT for any condition
结局指标
主要结局
Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI)
时间窗: During radiation therapy (5-10 days)
Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving PBI compared to historical rates of toxicity of patients receiving WBI
时间窗: Post therapy (until death)
次要结局
- Survival Rates(5 years)
- Cosmetic outcomes of breast PBI(3 years)