Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
研究概览
简要总结
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.
The names of the two study groups in this research study are:
- Proton Radiation Therapy (PBT)
- Conventional or "Photon" Radiation Therapy (XRT)
详细描述
This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.
Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.
Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.
The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
- •Prior chemotherapy is permitted
- •Ability to understand and the willingness to sign a written informed consent document
- •No contraindication to MRI
- •Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.
排除标准
- •Person who is pregnant or breastfeeding.
- •Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
- •Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
- •Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
结局指标
主要结局
Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
时间窗: Up to 7 months (pre-treatment period to 6 month follow up)
The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.
次要结局
- Change in Global Longitudinal Strain (GLS) on CMR from Baseline(Up to 7 months (pre-treatment period to 6 month follow up))
- Stability of Cardiac Biomarkers from Baseline(Up to 7 months (pre-treatment period to 6 month follow up))
- Body Image Evaluation(Up to 13 months (pre-treatment period to 12 month follow up))
- Change in Shoulder Function from Baseline(Up to 13 months (pre-treatment period to 12 month follow up))
研究者
Rachel Beth Jimenez
Principal Investigator
Massachusetts General Hospital