NCT01365845已完成不适用
Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
研究概览
简要总结
The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
- •Patients must have undergone either mastectomy or breast conservation surgery.
- •Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
- •Patient must require peripheral lymph node radiation per physician discretion.
排除标准
- •Evidence of distant metastasis (M1).
- •Prior radiotherapy to the area of interest.
- •Prior history of cardiovascular disease per physician discretion.
- •Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
- •Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
结局指标
主要结局
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
时间窗: 2 weeks prior to starting radiation therapy.
A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.
次要结局
- Secondary Dosimetric Endpoint(2 weeks prior to starting radiation therapy.)
- Assessment of Cardiac Function Markers(after treatment)
- Assessment of Longterm Side Effects and Disease Specific End Points.(1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.)
- Assessment of Acute Side Effects(Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.)
研究者
研究点 (2)
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