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临床试验/NL-OMON45136
NL-OMON45136已完成不适用

Breast conserving therapy using Accelerated Partial Breast Irradiation (APBI) in elderly patients: a feasibility study - Breast conserving therapy using APBI in elderly patients

Haaglanden Medisch Centrum0 个研究点目标入组 509 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
509

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • Histological confirmed breast cancer (DCIS and invasive) ductal subtypes
  • T1-2 smaller than 30mm as determined by ultrasound
  • N0 on palpation and ultrasound examination
  • Unicentric, Unifocal disease (radiological), multifocal when limited within 2 cm of the index lesion)
  • Any hormonal receptor status, hormonal therapy allowed following Dutch treatment guidelines
  • Technically eligible for lumpectomy or radiotherapy
  • No contra indications for lumpectomy and sentinal node procedure
  • Written informed consent
  • Willing to fill out the QOL, geriatric- and co morbidity questionaires - if applicable

排除标准

  • Patients not eligible / fit for lumpectomy and sentinal node procedure
  • pT2 (>30mm), pT3 and pT4
  • Positive surgical margins
  • Multi centricity; multifocal (> 2cm from the index lesion)
  • Extensive intraductal carcinoma; lympho-vascular invasion
  • Previous treatment of ipsilateral breast tumor (DCIS or invasive)
  • Paget disease of the nipple
  • Cutaneous involvement
  • Distant metastases; > pN1a
  • Previous radiotherapy on the ipsilateral breast
  • neo adjuvant chemotherapy for current malignancy
  • Collagen diseases (systematic erythematosus lupus, scleroderma, dermatomyositis)
  • Psychiatric diseases or other that prevents signing of informed consent
  • Other neoplasm's in the last 5 year with exception of skin tumors (excl melanoma) and intraepthelial lesions of the cervix uteri

研究者

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