Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Number of Patients Requiring 2nd Surgery for Close or Positive Margins
研究概览
简要总结
In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.
详细描述
While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (< 3 mm) which occurs on average in ~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, 18-100 years old
- •Not pregnant or breastfeeding
- •Pre-study radiologic documentation of:
- •size ≤ 5 cm
- •unicentric, unilateral
- •suspicious mass or calcification
- •BIRADS classification ≥ IV
- •location of abnormality > 1 cm from skin
- •Ductal or Infiltrating Ductal Carcinoma
- •Grade I-III on final pathology
- •Good general health
- •Zubrod Performance Status of 0,1, or 2
- •No previous chemotherapy
- •No palpable axillary or supraclavicular lymph nodes
- •If prior non-breast malignancy, must have > 5 year disease-free survival
排除标准
- •Patient < 18 y/o or > 100 y/o
- •Pregnant or breastfeeding
- •Breast implants
- •Multicentric disease or bilateral disease
- •Lesions > 5 cm in diameter
- •Lesions < 1.0 cm from the skin
- •Previous prior radiation to the breast
- •Need for mastectomy
- •Diffuse microcalcifications (as determined by the Investigator)
结局指标
主要结局
Number of Patients Requiring 2nd Surgery for Close or Positive Margins
时间窗: Margins assessed at Final Pathology, approximately 1 week post-RF surgery
A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.
次要结局
- Recurrence of Breast Cancer at Prior Site of Disease(Until study end (2 years))