ACTRN12606000523505已完成3 期
Trans Tasman Radiation Oncology Group (TROG) 03.05 - A phase III study of regional radiation therapy in early breast cancer to improve overall survival.
ational Cancer Institute of Canada (NCIC)0 个研究点目标入组 1,822 人开始时间: 2003年12月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,822
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Histologically proven invasive carcinoma of the breast and no evidence of metastatic disease.- Investigations, including ER receptor status, and chest x-ray, and any additional investigations to rule out metastatic disease performed within 9 months prior to randomization.- A history and physical exam including weight, performance status and measurement of upper andlower arm circumferences performed within 12 weeks prior to randomization.- A bilateral mammogram performed within 12 months prior to randomization.- Patients must have been treated with Breast conservation therapy (BCT) (eg. lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy and considered a candidate for breast radiation. - Patients must be at high risk of regional recurrence, due to 1) pathologically positive axillary nodes, or2) pathologically negative axillary nodes anda) primary tumor > 5 cm orb) primary tumor > 2 cm and <10 axillary nodes removed and one of the following: ER negative, Skarf-Bloom-Richardson (SBR) grade 3 or lymphovascular invasion.Note: Patients with sentinel node dissection are eligible if they are node negative but still meet thehigh risk criteria. However, if they are node positive, a level I and II axillary dissection must be performed.- Patients must be treated with adjuvant systemic treatment, either currently accepted chemotherapy and/or hormonal therapy. (Patients may also have planned chemotherapy concurrently with theirradiation therapy.)- Performance status must be Eastern Cooperative Onocology Group (ECOG) 0, 1, or 2.- Patients should be planned and started on radiation as soon as possible after randomization.- Protocol treatment (radiotherapy) must begin within 8 weeks of the completion of adjuvant chemotherapy, unless radiotherapy is given concurrently with chemotherapy (ie CMF), or within 16weeks of the last surgical procedure for patients receiving hormonal therapy only.Patient’s life expectancy is >5 years- Women of childbearing potential must be using adequate contraception while receiving radiotherapy.
排除标准
- •Clinical evidence prior to surgery of T4 or N2-3 disease (UICC, 1997)- Evidence of residual disease in the axilla following dissection.- Serious non-malignant disease (e.g., cardiovascular, renal, pulmonary, systemic lupus erythematosis-SLE, scleroderma) which would preclude definitive surgical or radiation treatment.Note: Radiation therapy may not be recommended for patients with connective tissue disorders such as Lupus or Scleroderma.- Currently pregnant or lactating.- Women of childbearing age must be using adequate contraception while on treatment.- Concurrent and previous malignancies except non melanoma skin cancer; carcinoma in situ of the cervix or endometrium; contralateral non-invasive breast cancer (unless previous radiation to the contralateral breast). Also, invasive carcinoma of the cervix, endometrium, colon, thyroid, and melanoma treated five years prior to study entry and presumed cured are permitted on study.- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
研究者
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