Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast. Feasibility will be determined by the rate of good/excellent cosmesis, as measured by the Radiation Therapy Oncology Group (RTOG) cosmetic rating scale, in patients treated with this regimen compared with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517.
- Determine the incidence of grade 3-4 toxicity of this regimen in these patients.
- Determine the rate of ipsilateral breast recurrence, including recurrence within the tumor bed as compared to elsewhere in the breast, in patients treated with this regimen.
Secondary
- Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen.
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
- 48 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed primary invasive ductal carcinoma of the breast
- •Tumor size ≤ 3 cm
- •No extensive intraductal component
- •Tumor must not be attached to the skin, underlying muscle, or chest wall
- •Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist
- •Tumor amenable to segmental mastectomy (i.e., lumpectomy)
- •No bilateral breast cancer
- •No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
- •Patients with > 1 tumor mass in the same breast must have only 1 mass that is histologically malignant AND all other masses must be proven histologically benign
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •48 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •At least 5 years
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant
- •Fertile patients must use effective contraception
- •No collagen vascular disease
- •No medical condition that would preclude surgery
- •Other prior malignancy allowed provided the following criteria are met:
- •Patient has undergone potential curative therapy for all prior malignancies
- •There is no evidence of any prior malignancy within the past 5 years
- •Patient is deemed to be at low risk for recurrence of prior malignancy, as determined by the treating physician
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for this malignancy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the breast
- •No breast implants
排除标准
- 未提供
研究组 & 干预措施
Intraoperative Radiation Arm
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
干预措施: surgery (Procedure)
Intraoperative Radiation Arm
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
干预措施: therapy (Procedure)
Intraoperative Radiation Arm
Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician
时间窗: 1 year follow up visit
Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Ipsilateral Breast Recurrence
时间窗: 5 years
Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients
时间窗: 1 year follow up visit
Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Incidence of Grade 3/4 Toxicity
时间窗: 3 months
Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline: Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event
次要结局
- Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT(3 months)
- Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT(3 months)
- Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT(3 months)