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临床试验/NCT01045187
NCT01045187已完成不适用

Feasibility Study Using the Xoft Axxent Electronic Brachytherapy System for the Treatment of Endometrial Cancer

Xoft, Inc.12 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Xoft, Inc.
入组人数
15
试验地点
12
主要终点
Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System

研究概览

简要总结

Multicenter, non-randomized, feasibility study to evaluate the treatment and assess acute safety of the FDA Cleared Axxent Electronic Brachytherapy System and vaginal applicator for intracavitary vaginal cuff treatment according to the physician's current standard of care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • Most types of endometrial (uterine) cancer Stage I and Stage II (see exclusion criteria below)
  • Post hysterectomy

排除标准

  • Endometrial (uterine) cancer Stage IA Grade 1
  • Scleroderma
  • Collagen vascular disease
  • Active Lupus

结局指标

主要结局

Assess Number of Patients Who Were Able to Complete Treatment Delivery Using the Axxent Electronic Brachytherapy System

时间窗: through completion of radiation therapy

次要结局

  • Assess Acute Safety Outcomes in Patients During and After Vaginal Cuff Brachytherapy Treatment With the Axxent Electronic Brachytherapy System as Incorporated in to the Physician's Current Standard of Practice(through 3 month post treatment)
  • Assess Occurence Rate of Toxicities(through 3 month follow up post treatment)

研究者

发起方
Xoft, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (12)

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