Breast Cancer, Large-segment Radiotherapy, Optical Surface Monitoring Technology
Conditions
Keywords
breast cancer, optical surface monitoring technology, large-segment radiotherapy
Brief summary
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
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.
Interventions
DEVICESurface Guided Radiation Therapy (SGRT)
SGRT and DIBH those two devices could be combined together to improve the accuracy in radiation therapy position and heart protection
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who have undergone breast-conserving surgery or modified radical mastectomy for left breast cancer; 2. Planned whole-breast ± supraclavicular region, chest wall ± supraclavicular region radiotherapy; 3. Able to perform deep inspiration breath-hold technique with breath-holding time \>35s and can repeat it continuously for more than 6 times; 4. Patients who have not received neoadjuvant chemotherapy or breast reconstruction surgery; 5. No active heart disease, myocardial infarction, congestive heart failure or other cardiac diseases at baseline; 6. Patients are fully voluntary and able to sign the informed consent form 30 days before enrollment.
Exclusion criteria
1. Bilateral breast cancer; 2. No pathological diagnosis; 3. Remote metastasis; 4. Receiving neoadjuvant chemotherapy or breast reconstruction; 5. Have received mediastinal radiotherapy in the past; 6. Previous history of abdominal or pelvic radiotherapy; 7. Previous or secondary primary malignant tumor; 8. Serious cardiac insufficiency; Myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina pectoris occurred in the last 3 months; Pericardial disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of treatment location | 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 | 3-year | including the cardiac enzymes, ECG and myocardial perfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary efficacy indicators | 3-year | Correlation between surface optical monitoring technology and CBCT offset values Correlation between positioning errors and dose pass rates Patient position movement within fractions |
| cardiac safety | 5-year | cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc |
| patients' quality of life | 5-year | scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome. |
Countries
China
Contacts
Primary ContactXiaorong HOU, PhD
Backup ContactFuquan ZHANG, PhD
Outcome results
None listed