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Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.
Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase II open lable Study | Experimental | Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of relieve pain | According to the Numerical Rating Pain Scale (NRPS) | One week after radiation to 2 years late |
| Measure | Description | Time Frame |
|---|---|---|
| The degree of relieve pain | According to the Numerical Rating Pain Scale (NRPS) | One week after radiation to 2 years late |
| The duration relieve pain | According to the Numerical Rating Pain Scale (NRPS) |
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Inclusion Criteria:
Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
Exclusion Criteria:
9.refused to signed informed consent;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Ye, Master | Contact | +862168383459 | renjiyeming@163.com | |
| Qi Lu, Master | Contact | +8621-58752345 | 33364 | luqi@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Ye, Master | Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011471 | Prostatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.
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|
| One week after radiation to 2 years late |
| The incidence of toxicity | Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | One week after radiation to 2 years late |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |