跳至主要内容
临床试验/NL-OMON54499
NL-OMON54499已完成3 期

Clinically node negative breast cancer patients undergoing breast conserving therapy: Sentinel lymph node procedure versus follow-up. A Dutch randomized controlled multicentre trial. - BOOG 2013-08

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 1,730 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
1,730

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Aged 18 years or older
  • - Pathologically confirmed invasive unilateral breast carcinoma
  • - A clinical T1-2 tumour (<= 5cm)
  • - Will be treated with lumpectomy followed by whole breast radiotherapy
  • - Clinically node negative status: no signs of axillary lymph node metastases
  • at physical examination and preoperative axillary ultrasound (or negative
  • cyto-/histopathology)
  • - Written informed consent

排除标准

  • - Clinically node positive pre-operative
  • - Bilateral breast cancer
  • - Evidence of metastatic disease
  • - History of invasive breast cancer
  • - Previous treatment of the ipsilateral axilla with surgery or radiotherapy,
  • except surgery for hidradenitis suppurativa or for other superficially located
  • skin lesions, such as naevi
  • - Pregnant or nursing
  • - Other prior malignancies within the past 5 years, except successfully treated
  • malignancies that occurred more than five years before randomization, and
  • except successfully treated basal cell and squamous cell skin cancer, carcinoma
  • in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral
  • - Unable or unwilling to give informed consent

研究者

发起方
Medisch Universitair Ziekenhuis Maastricht

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