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临床试验/ACTRN12613000551796
ACTRN12613000551796招募中2 期

In women diagnosed with localised breast cancer, does Accelerated Partial Breast Irradiation (APBI) demonstrate acceptable general cosmesis with an improved quality of life?

Dr Yaw Chin.0 个研究点目标入组 60 人开始时间: 2013年5月16日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
50 Years 至 80 Years(—)
性别
Female

入选标准

  • a) Females more than 50 years of age.
  • b) Performance status 0-2.
  • c) Unicentric, invasive ductal carcinoma measuring 3cm in maximal diameter or less.
  • d) Negative surgical resection margins, defined as no tumour at the inked margins.
  • e) No extensive intraductal component, as defined by >25% of the invasive ductal tumour being comprised of intraductal carcinoma or ductal carcinoma in-situ being also present in the adjacent breast tissue.
  • f) No lymphovascular invasion.
  • g) No cutaneous involvement, including Paget’s disease of the nipple, oedema (peau d’orange) or inflammatory carcinoma.
  • h) No axillary nodal involvement on sentinel node biopsy or axillary nodal dissection.
  • i) No distant metastases.
  • j) A clearly defined surgical excision cavity and a planning target volume to whole breast volume ratio of >25%, based on the postoperative CT scan.
  • k) Provision of verbal and written consent, including willingness to comply with the specified treatment protocol, follow-up visits and examinations.

排除标准

  • a) Locally recurrent breast cancer.
  • b) History of concurrent or previous malignancies (except for non-melanomatous skin cancer or carcinoma in-situ of the uterine cervix).
  • c) Her-2 receptor positive tumours.
  • d) Microscopic assessment of tumour resection margins cannot be defined accurately.
  • e) Women who are pregnant or lactating.
  • f) Pre-existing connective tissue disorder such as scleroderma, systemic lupus erythematosis and dermatomyositis.
  • g) Patients with ipsilateral breast implants.
  • h) Previous radiation treatment to the ipsilateral breast or thoracic region.
  • i) Psychiatric or addictive disorders that preclude patients from giving informed consent.

研究者

发起方
Dr Yaw Chin.

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