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临床试验/NCT00614172
NCT00614172已完成不适用

Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer

Loma Linda University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Ipsilateral Breast Tumor Recurrence-free Survival

研究概览

简要总结

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

详细描述

Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.

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

入选标准

  • Invasive ductal, medullary, papillary, colloid or tubular histologies
  • Stages T1 or T2 (tumors < or = 3 cm) from lumpectomy specimen.
  • No more then 3 positive nodes on axillary dissection or negative sentinel node.
  • Negative surgical margins (>2mm)

排除标准

  • Invasive lobular histology
  • Previous chemotherapy for breast cancer
  • Extensive intraductal component
  • Collagen vascular disease
  • Prior malignancy unless disease-free for 5 years
  • Patients who are pregnant or lactating

结局指标

主要结局

Ipsilateral Breast Tumor Recurrence-free Survival

时间窗: Up to 5 years post-treatment completion, average of 48 months

Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam

次要结局

  • Overall Survival(Up to 5 years post- completion of treatment, average 48 months)

研究者

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

David Bush

Principal Inverstigator

Loma Linda University

研究点 (2)

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