Optical Surface Monitoring Technology-Guided Large-Segment Radiotherapy for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Cancer, Optical Surface Monitoring Technology, Large-segment Radiotherapy

Intervention / Treatment
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* Device: Surface Guided Radiation Therapy (SGRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGRT+DIBH group<br>Patients with left breast cancer treated with SGRT combined with DIBH technique | Device: Surface Guided Radiation Therapy (SGRT)<br>* SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection<br>* Other names: Deep Inspiration Breath Hold (DIBH) technique;|
| No Intervention: common+Free breath group<br>Patients with left breast cancer treated with traditional laser alignment with free breathing treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, optical surface monitoring technology, large-segment radiotherapy