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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGRT+DIBH group | Experimental | Patients with left breast cancer treated with SGRT combined with DIBH technique |
|
| common+Free breath group | No Intervention | Patients with left breast cancer treated with traditional laser alignment with free breathing treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surface Guided Radiation Therapy (SGRT) | Device | SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy 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 | Change from baseline to the whole treatment procedure |
| Incidence of patient coronary events/myocardial perfusion decline | including the cardiac enzymes, ECG and myocardial perfusion | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3-year |
| cardiac safety |
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Inclusion Criteria:
Exclusion Criteria:
aged 18-70, with an expected lifespan of >5 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaorong HOU, PhD | Contact | +86-13811963013 | hxr_pumch@163.com | |
| Fuquan ZHANG, PhD | Contact | +86-13311360431 | zhangfuquan3@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Control group: Patients with left breast cancer treated with traditional laser alignment with a free breathing treatment Study group: Patients with left breast cancer treated with SGRT combined with the DIBH technique
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Open Label
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|
cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc
| 5-year |
| patients' quality of life | scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome. | 5-year |
| D017437 |
| Skin and Connective Tissue Diseases |