NCT03585621进行中（未招募）不适用
A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)
Toronto Sunnybrook Regional Cancer Centre2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Acute toxicity
研究概览
简要总结
This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
- •Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.
- •Primary breast and axillary surgery not recommended/performed due to any of the following:
- •distant metastatic disease
- •unresectable T4 disease and/or
- •medically inoperable and/or
- •patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.
排除标准
- •Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease >= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy > 50% of the ipsilateral whole breast volume.
- •Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.
- •scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
- •Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol
结局指标
主要结局
Acute toxicity
时间窗: 12 weeks post treatment
Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0
次要结局
- Breast Symptom Scores(2 years post treatment)
- Patient Reported Pain Level(2 years post treatment)
- Tumour Response Rate(2 years post treatment)
- Patient Reported Quality of Life(2 years post treatment)
研究者
Danny Vesprini, MD, MSc, FRCPC
Deputy Chief, Department of Radiation Oncology - Clinical Care
Toronto Sunnybrook Regional Cancer Centre
研究点 (2)
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