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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-PUMCH-B-116 | Other Grant/Funding Number | Peking Union Medical College Hospital |
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The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique | Experimental | Patients with left breast cancer treated with Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique |
|
| laser alignment combined with free breathing treatment | Active Comparator | Patients with left breast cancer treated with traditional laser alignment with free breathing treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Large Segmentation Radiotherapy | Radiation | Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subclinical and clinical cardiac events |
| through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Localized regional control rate ,overall survival and disease-related survival. | through study completion, an average of 1 year |
| Cosmetic results | cosmetic evaluation(breast-conserving surgery). Excellent: The treated mammary gland is indistinguishable or only slightly different in size, shape, and texture from the contralateral mammary gland. There may be mild thickening of the breast or skin, or scar tissue, but not enough to change the appearance of the colored gland. Good: The treated breast is not mildly asymmetric in size or shape compared to the contralateral breast. Thickening or scar tissue in the breast causes only Fair: The treated breast is significantly different in size and shape from the contralateral breast. Such changes involving 1/4 or less of the treated breast are significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue. Poor: The treated breast is significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue or the treated breast has severe sequelae. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaorong Hou | Contact | +86 13811963013 | hxr_pumch@163.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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| DIBH | Device | Deep Inspiration Breath Hold |
|
| Surface guided radiation therapy | Device | The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment. |
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| laser alignment | Device | Laser systems for virtual simulation and patient positioning in radiotherapy |
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| free breathing | Behavioral | Patients breathe calmly while radiotherapy instead of holding their breath. |
|
| through study completion, an average of 1 year |
| Life quality | Assessment of patient quality of life by EORTC QLQ-BR23 , a higher score means worse life quality. | through study completion, an average of 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |