Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
研究概览
简要总结
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
详细描述
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing.
Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 invasive breast cancer confined to the breast and regional lymphatics
- •Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery
- •Life expectancy > 12 months
排除标准
- •Pregnant or breast-feeding
- •Prior therapeutic radiation > 200 cGy
- •History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin
- •Prior investigation chemotherapy
研究组 & 干预措施
Proton Radiation
Radiation therapy with proton beam
干预措施: Proton Radiation (Radiation)
结局指标
主要结局
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
时间窗: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or \> radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
次要结局
- The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy(Baseline and then 4 and 8 weeks post treatment)
- The Number of Participants With Acute Skin Toxicities(From the start of treatment until 3 months after the end of treatment)
- Rate and Severity of Radiation Pneumonitis(From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.)
- Summary of Late Skin Toxicity(From 3 months after the end of treatment up to 5 years)
- Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation(From the start of treatment until 5 years post treatment)
- Progression Free Survival(from the start of treatment until the time of disease progression, up to 5 years)
- To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome(From the start of treatment until 5 years post treatment)
- The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction(From the start of treatment until 5 years post treatment)
研究者
Rachel Beth Jimenez
Principal Investigator
Massachusetts General Hospital