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临床试验/NCT04603209
NCT04603209招募中不适用

Research Registry for Intra-Operative Radiotherapy (IORT) During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer

Saint John's Cancer Institute1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Disease Recurrence

研究概览

简要总结

This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.

详细描述

At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT.

As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification)
  • Unifocal Disease
  • Candidate for breast-conserving surgery
  • Recommended treatment by multidisciplinary team

排除标准

  • Clinical stage T3-4, N1-3, M1
  • Multifocal disease

结局指标

主要结局

Disease Recurrence

时间窗: 5 years

Presence of recurrent tumor in ipsilateral breast or distant site

次要结局

  • Disease specific survival(10 years)
  • Overall Survival(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janie Grumley

Director of the Comprehensive Breast Program, Margie Petersen Breast Center

Saint John's Cancer Institute

研究点 (1)

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