NCT01008514撤回2 期
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Proportion of local recurrence
研究概览
简要总结
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
详细描述
OBJECTIVES:
Primary
- To examine the efficacy of MammoSite® Radiation Therapy System (RTS) in delivering partial-breast irradiation to women with early-stage breast cancer.
Secondary
- To assess the toxicities associated with MammoSite® RTS in these patients.
- To evaluate the cosmetic results in the breast after brachytherapy with the MammoSite® RTS.
- To correlate the cosmetic results with the use of chemotherapy, volume of the implant, and distance from the implant to the skin.
- To correlate the local recurrence rate with time between surgery and implant.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma
- •Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
- •Pathologic staging of the axilla preferred
- •Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
- •Unicentric tumor
- •Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
- •Must have undergone lumpectomy as definitive surgery
- •Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery
- •Re-excision to obtain negative margins allowed
- •Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
- •No multicentric carcinoma (invasive or DCIS) in more than one quadrant
- •No clinically or pathologically positive regional lymph nodes
- •No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing > 25% of the primary tumor
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No collagen-vascular disease, including any of the following:
- •Dermatomyositis
- •Systemic lupus erythematosus
- •Scleroderma-mixed connective tissue disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Proportion of local recurrence
时间窗: up to 5 years
* Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. * Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
次要结局
- Safety and toxicity(up to 30 months after radiotherapy)
- Cosmetic results(up to 30 months)
研究者
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