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Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
Eligible breast cancer patients with bone metastases will be treated with FSRT. 9-10 Gy x 3Fx or 6-7 Gy x 5Fx image-guided fractionated stereotatic radiation therapy will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractionated Stereotatic Radiation Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractionated Stereotatic Radiation Therapy | Radiation | Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control Rate | Determine the local control rate of FSRT in patients with bone metastasis of breast cancer | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Control | Evaluate whether FSRT improves pain control as measured by Brief Pain Inventory (BPI) after FSRT in patients with spinal metastasis of breast cancer | 3 years |
| Overall Survival | Time from the date of informed consent until to the date of death, regardless of the cause of death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaozhi Yang, MD, Ph.D | Contact | 8618017317126 | yzzhi2006@yahoo.com.cn | |
| Wei Shi, MD, Ph.D | Contact | 8618121299680 | wei.shi118@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaozhi Yang, MD, Ph.D | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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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|
| 3 years |
| Progression Free Survival | Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first | 3 years |
| Quality of Life | Evaluate the quality of life according to EORTC QLQ-BM22 | 3 years |
| Vertebral Fracture and Radiation Myelitis | Determine the incidence of bone fracture and radiation myelitis | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |