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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
556
SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGAccuracy of treatment location
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
Time frame: Change from baseline to the whole treatment procedure
Incidence of patient coronary events/myocardial perfusion decline
including the cardiac enzymes, ECG and myocardial perfusion
Time frame: 3-year
Secondary efficacy indicators
Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions
Time frame: 3-year
cardiac safety
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
Time frame: 5-year
patients' quality of life
scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome.
Time frame: 5-year
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