NCT00388115已完成不适用
A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy
研究概览
简要总结
RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.
详细描述
OBJECTIVES:
Primary
- Determine the effectiveness of radiofrequency ablation (RFA), in terms of amount of tumor coagulated and viable cell count, in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ.
Secondary
- Determine the size, configuration, and pathological features of human breast tumors after treatment with RFA.
- Determine whether RFA energy applied to breast cancer will result in cancer cell death.
- Determine whether tumor-free margins are achieved by RFA in these patients.
- Determine the rate of acute toxicities to skin after surgery 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females of ages ≥18 years.
- •Core biopsy proven invasive breast cancer OR
- •Core biopsy proven low or intermediate grade DCIS.
- •Tumor less than or equal to 2.0 cm in diameter.
- •No prior surgical treatment for breast cancer within 30 days.
- •Life expectancy of > 10 years, not including the diagnosis of cancer.
- •ECOG performance status of 0-
- •Informed consent given.
- •Multifocal invasive breast cancer patients are eligible. All tumors that are palpable or visualized by USS can be treated.
排除标准
- •Male subjects.
- •Ages < 18 years.
- •Breast tumor > 2.0 cm in diameter.
- •Evidence of distant metastatic disease.
- •Evidence of diffuse calcification suggestive of extensive or multifocal DCIS.
- •High grade DCIS or presence of comedo-necrosis because these lesions can be associated with invasive breast cancer, which would go undetected if the lesion is entirely destroyed by the RF ablation.
研究组 & 干预措施
RFA prior to surgery
Experimental
干预措施: conventional surgery (Procedure)
RFA prior to surgery
Experimental
干预措施: neoadjuvant therapy (Procedure)
RFA prior to surgery
Experimental
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy
时间窗: At completion of study
次要结局
- Rate of acute skin toxicity(At completion of study)
- Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy(At completion of study)
- Number and proportion of patients with and without tumor in the margin(At completion of study)
研究者
研究点 (1)
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