NCT02186470已完成不适用
Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
研究概览
简要总结
This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
详细描述
PRIMARY OBJECTIVES:
Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.
SECONDARY OBJECTIVES:
- To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
- To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
- Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
- Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI
OUTLINE:
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- •Patient must be ≥ 50 years
- •Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.
- •Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.
- •The patient must have clinical node negative, stage I breast cancer.
- •The surgical treatment must be intended to be a lumpectomy
- •The biopsy site must have been demarcated by a clip(s)
- •Gross disease must be unifocal on Mammo/ MRI imaging
- •Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy
- •Patient must be able to tolerate lying in the prone position with arms extended forward.
- •Must be able to tolerate MRI scan with contrast
- •At the time of enrollment, patients must have had bilateral mammograms within 6 months.
- •Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.
- •Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
排除标准
- •Age < 50 years
- •Hormone unresponsive breast cancer
- •T-2 ( > 3.0 cm), T-3, Stage III, or Stage IV breast cancer.
- •N-1, N-2, or N-3 clinical axillary nodes
- •Mastectomy intended
- •Unwilling to undergo anti-endocrine therapy
- •Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Paget's disease of the nipple
- •Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by > 4 centimeters.
- •Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment.
- •Prior breast or thoracic RT for any condition.
- •Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements.
结局指标
主要结局
The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method
时间窗: 4-6 weeks post-APBI
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).
次要结局
- Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0(Up to 5 years)
- Cosmetic outcome by the physician and patient(At year 3)
- Disease free survival(Up to 5 years)
- Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs(Up to 4 weeks post-surgery)
- Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0(Up to 4 weeks post-surgery)
- In-breast recurrence(Up to 5 years)
- Regional recurrence(Up to 5 years)
- Distant metastases(Up to 5 years)
- Overall survival(Up to 5 years)
研究者
Sasha Beyer
Principal Investigator
Ohio State University Comprehensive Cancer Center
研究点 (2)
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