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
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