Breast Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 556 |
Est. completion date | April 1, 2027 |
Est. primary completion date | April 1, 2027 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Incidence of patient coronary events/myocardial perfusion decline | including the cardiac enzymes, ECG and myocardial perfusion | 3-year | |
Secondary | 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 | |
Secondary | cardiac safety | cardiac injury events include myocardial enzymes, electrocardiogram, echo, etc | 5-year | |
Secondary | patients' quality of life | scale scores of EORTC-QLQ-BR23, 0-100 scores, higher scores mean a better outcome. | 5-year |
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