A Single-center, Blinded, Efficacious, Phase III Randomized Clinical Trial Initiated by Investigators to Investigate the Use of Surface Guided Radiation Therapy (SGRT) in Combination With Deep Inspiration Breath Hold (DIBH) Technique for Left Breast Cancer Treatment, Compared to Traditional Laser Alignment With Free Breathing Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Accuracy of treatment location
研究概览
简要总结
This study is a single-center,blinded, efficacious, phase III randomized clinical trial initiated by investigators. The primary objective is to investigate the use of Surface Guided Radiation Therapy (SGRT) in combination with Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment, compared to traditional laser alignment with free breathing treatment. This approach offers superior positioning accuracy and improved heart protection without any increase in radiation or adverse reactions.
详细描述
This is an investigator-initiated blinded, efficacious, phase III randomized clinical trial study. The study hypothesis is that the use of Surface Guided Radiation Therapy (SGRT) in combination with the Deep Inspiration Breath Hold (DIBH) technique for left breast cancer treatment can improve positioning accuracy and heart protection without any increase in radiation or adverse reactions. The primary endpoint of this study is the accuracy of the treatment location and incidence of patient coronary events/myocardial perfusion decline.
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
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer;
- •Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy;
- •Able to perform deep inspiration breath-hold technique with breath-holding time >35s and can repeat it continuously for more than 6 times;
- •Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery;
- •No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline;
- •Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.
排除标准
- •Bilateral breast cancer;
- •No pathological diagnosis;
- •Remote metastasis;
- •Receiving neoadjuvant chemotherapy or breast reconstruction;
- •Have received mediastinal radiotherapy in the past;
- •Previous history of abdominal or pelvic radiotherapy;
- •Previous or secondary primary malignant tumor;
- •Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
结局指标
主要结局
Accuracy of treatment location
时间窗: Change from baseline to the whole treatment procedure
surface optical monitoring technology and simulation of surface contour registration error generated by surface optical surface error, as well as errors obtained by Cone beam CT registration. The translational errors in the left-right (x), up-down (y), front-back (z) directions, and rotational errors Rx, Ry, Rz will be measured
Incidence of patient coronary events/myocardial perfusion decline
时间窗: 3-year
including the cardiac enzymes, ECG and myocardial perfusion
次要结局
- Secondary efficacy indicators(3-year)
- cardiac safety(5-year)
- patients' quality of life(5-year)