跳至主要内容
临床试验/NCT00210223
NCT00210223已完成不适用

Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

Institut Bergonié2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Number of Participants With Disease Recurrence One Year After the Intervention.

研究概览

简要总结

To determine the efficacy and tolerance of ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy in elderly patients with breast cancer who decline or are not candidates for surgery.

详细描述

There is increasing demand for minimally invasive treatments for small breast malignancies. This is due in part to increased availability of improved treatment approaches, with the introduction of neoadjuvant strategies, and for cosmetic reasons. Moreover, with the introduction of breast cancer screening programs, tumors are frequently diagnosed earlier and at a smaller size, enabling breast-conserving treatment with lumpectomy followed by whole-breast radiation therapy. For elderly patients, however, various physiologic alterations, comorbid diseases, and higher risk of complications are often perceived as contraindications to breast-conserving methods). In addition, elderly cancer patients generally receive fewer surgeries than younger patients. In this context, radiofrequency (RF) ablation is emerging as a minimally invasive nonsurgical technique for the treatment of small breast malignancies. Several pilot studies have published RF ablation tolerance and feasibility results for patients of all ages with small breast cancers and for small cohorts of elderly patients, but there is a lack of prospective data on long-term follow- up and long-term efficacy for elderly patients. In this prospective, single-arm study, we aimed to determine the efficacy and patient tolerance of ultrasonography (US)-guided percutaneous RF ablation with endocrine therapy for elderly patients with breast cancer who decline or are not candidates for surgery.

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
70 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With Disease Recurrence One Year After the Intervention.

时间窗: one year

The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy. Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging).

次要结局

  • Number of Participants With Disease Recurrence at 5 Years(5 years after the intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验