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| Name | Class |
|---|---|
| Mianyang Central Hospital | OTHER |
| Second Hospital of Shanxi Medical University | OTHER |
| Qingdao chengyang hospital | UNKNOWN |
| Qingdao Hiser Medical Group |
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Data of 100 patients with spinal metastatic tumor who received stereotactic radiotherapy or conventionally-fractionated image-guided intensity-modulated radiotherapy in the multi-center of the research group from July 2019 to June 2021 will be collected, as well as their follow-up data.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
In this study, Data of 100 patients with spinal metastatic tumor who received stereotactic radiotherapy or conventionally-fractionated image-guided intensity-modulated radiotherapy in the multi-center of the research group from July 2019 to June 2021 will be collected, as well as their follow-up data.The metastases were treated with SBRT.Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10).The metastases were treated with Conventionally-fractionated image- guided Intensity modulated radiotherapy.Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic radiotherapy | Experimental | In this study, the metastases were treated with Stereotactic radiotherapy(SBRT).Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10). Stereotactic radiotherapy |
|
| Conventionally-fractionated image- guided Intensity modulated | Experimental | In this study, the metastases were treated with Conventionally-fractionated image- guided Intensity modulated radiotherapy.Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic radiotherapy | Radiation | Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10). |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer pain score | Numerical grading (NRS) should be used for pain intensity assessment, and facial expression pain scoring should be used for patients with difficulty in expression. | 1 year after the treatment |
| Muscle strength and muscle tension grading | Muscle strength and muscle tension were graded by Numbers | 1 year after the treatment |
| JOA score of cervical and lumbar vertebrae | JOA score of cervical and lumbar vertebrae | 2 years after the treatment |
| Quality of Life Score of Tumor Patients(0-60) | Common methods for evaluating the quality of life of patients:The full score of quality of life is 60, the worst is < 20, the worse is 21-30, the average is 31-40, the better is 41-50, and the good is 51-60. | 2 years after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of pain response | Time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS | 1 years after the treatment |
| Overall survival | The time from enrollment to death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
Of the anatomy of the spinal metastases form Tomita classification: â…£, â…¤ â…¥, â…¦.
Participated in other drug clinical trials within four weeks; There was a history of bleeding, and any bleeding event with severe grade of CTCAE5.0 or above occurred within 4 weeks before screening;
Screening of patients with known central nervous system metastasis or a history of central nervous system metastasis. For patients with clinical suspected central nervous system metastasis, CT or MRI examination must be performed within 14 days before randomization to exclude central nervous system metastasis.
Patients with hypertension who cannot obtain good control by single antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg); Having a history of unstable angina pectoris; Patients newly diagnosed with angina within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmia (including QTcF: 450ms in male and 470ms in female) requires long-term use of anti-arrhythmia drugs and New York heart association grade II cardiac dysfunction;
Long-term unhealed wounds or incomplete fracture healing;
Imaging showed that the tumor had invaded important blood vessels or the researchers judged that the patient's tumor had a very high possibility to invade important blood vessels during the treatment and cause fatal bleeding;
Coagulation function is unusual, have haemorrhage tendency person (before random 14 days must satisfy: below the circumstance that does not use anticoagulant INR is in normal value range); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; The use of low-dose warfarin (1mg oral, once daily) or low-dose aspirin (no more than 100mg daily) for preventive purposes is permitted on the premise that the international standardized ratio of prothrombin time (INR) is 1.5;
Screening for the occurrence of hyperactive/venous thrombosis events in the first 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep vein thrombosis (except for venous thrombosis caused by intravenous catheterization in the early stage of chemotherapy, which was determined by the researchers to have recovered) and pulmonary embolism, etc.
Thyroid function was abnormal in the past and could not be kept within the normal range even in the case of drug treatment.
(10) Attending has a history of psychotropic drug abuse, and can't attend or has mental disorder;
Always half a year after spinal tumors or other close to the spine tumor lesion lesions radiation;
Immunodeficiency disease, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;
Judgment according to the researchers, there is serious to endanger the safety of patients or patients completed the research associated with disease.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjie Wang, MD | Contact | +860182264910 | junjiewang_edu@sina.cn | |
| Fei Xu, M Med | Contact | +8618511866032 | xufeibysy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Junjie Wang, MD | Peking University Third Hospital | Study Chair |
| Fei Xu, M Med | Peking University Third Hospital | Study Director |
| Hongqing Zhuang, M Med |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22181327 | Background | Massicotte E, Foote M, Reddy R, Sahgal A. Minimal access spine surgery (MASS) for decompression and stabilization performed as an out-patient procedure for metastatic spinal tumours followed by spine stereotactic body radiotherapy (SBRT): first report of technique and preliminary outcomes. Technol Cancer Res Treat. 2012 Feb;11(1):15-25. doi: 10.7785/tcrt.2012.500230. | |
| 23816297 |
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| OTHER |
| Beijing 302 Hospital | OTHER |
| Guangxi Ruikang Hospital | OTHER |
| Third Affiliated Hospital of Guizhou Medical University | UNKNOWN |
| Panjin Liaohe Oilfield Gem Flower Hospital | OTHER |
| Tang-Du Hospital | OTHER |
non-randomized trial
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|
| Conventionally-fractionated image- guided Intensity modulated radiotherapy | Radiation | Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy. |
|
| 3 years after the treatment |
| Local control rate | The rate at which lesions remained stable during follow-up | 3 years after the treatment |
| Adverse reactions | Adverse reactions during and after treatment | 6 months after the treatment |
| Progression-free survival | Time from treatment to cancer progression or death | 3 years after the treatment |
| Peking University Third Hospital |
| Principal Investigator |
| Xiaobo Du, MD | Mianyang Central Hospital | Principal Investigator |
| Jie Li, M Med | Mianyang Central Hospital | Principal Investigator |
| Xiang Song, M Med | Second Hospital of Shanxi Medical University | Principal Investigator |
| Lei Zhang, M Med | Second Hospital of Shanxi Medical University | Principal Investigator |
| Jianguo Zhang, M Med | Qingdao chengyang people's hospital | Principal Investigator |
| Peng Liu, M Med | Qingdao Hiser Medical Group | Principal Investigator |
| Xuezhang Duan, MD | Beijing 302 Hospital | Principal Investigator |
| Zuping Lian, MD | Guangxi Ruikang Hospital | Principal Investigator |
| Liang Liu, MD | Third Affiliated Hospital of Guizhou Medical University | Principal Investigator |
| Longhai Shen, M Med | Panjin Liaohe Oilfield Gem Flower Hospital | Principal Investigator |
| Dongjie He, M Med | Tang-Du Hospital | Principal Investigator |
| Xuemin Li, MD | Peking University Third Hospital | Principal Investigator |
| Yi Chen, MD | Peking University Third Hospital | Principal Investigator |
| The fifth medical center of PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
|
| Guangxi ruikang hospital | Recruiting | Nanning | Guangxi | 530000 | China |
|
| Third Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
|
| GEM flower hospital of Liaohe oil field Tang-Du Hospital | Recruiting | Panjin | Liaoning | 124010 | China |
|
| Hiser Medical Center of Qingdao | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Qingdao chengyang people's hospital | Recruiting | Qingdao | Shandong | 266000 | China |
|
| Second hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030000 | China |
|
| Tangdu hospital | Recruiting | Xian | Shanxi | 710000 | China |
|
| Mianyang Central Hospital | Recruiting | Mianyang | Sichuan | 621000 | China |
|
| Background |
| Sahgal A, Whyne CM, Ma L, Larson DA, Fehlings MG. Vertebral compression fracture after stereotactic body radiotherapy for spinal metastases. Lancet Oncol. 2013 Jul;14(8):e310-20. doi: 10.1016/S1470-2045(13)70101-3. |
| 15908648 | Background | Rades D, Stalpers LJ, Veninga T, Schulte R, Hoskin PJ, Obralic N, Bajrovic A, Rudat V, Schwarz R, Hulshof MC, Poortmans P, Schild SE. Evaluation of five radiation schedules and prognostic factors for metastatic spinal cord compression. J Clin Oncol. 2005 May 20;23(15):3366-75. doi: 10.1200/JCO.2005.04.754. |
| 18426607 | Background | Gong Y, Wang J, Bai S, Jiang X, Xu F. Conventionally-fractionated image-guided intensity modulated radiotherapy (IG-IMRT): a safe and effective treatment for cancer spinal metastasis. Radiat Oncol. 2008 Apr 22;3:11. doi: 10.1186/1748-717X-3-11. |
| 19250762 | Background | Guckenberger M, Goebel J, Wilbert J, Baier K, Richter A, Sweeney RA, Bratengeier K, Flentje M. Clinical outcome of dose-escalated image-guided radiotherapy for spinal metastases. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):828-35. doi: 10.1016/j.ijrobp.2008.11.017. Epub 2009 Feb 26. |
| 28041316 | Background | Zhang M, Chen YR, Chang SD, Veeravagu A. CyberKnife stereotactic radiosurgery for the treatment of symptomatic vertebral hemangiomas: a single-institution experience. Neurosurg Focus. 2017 Jan;42(1):E13. doi: 10.3171/2016.9.FOCUS16372. |
| 29224900 | Background | Gandhidasan S, Ball D, Kron T, Bressel M, Shaw M, Chu J, Chander S, Wheeler G, Plumridge N, Chesson B, David S, Siva S. Single Fraction Stereotactic Ablative Body Radiotherapy for Oligometastasis: Outcomes from 132 Consecutive Patients. Clin Oncol (R Coll Radiol). 2018 Mar;30(3):178-184. doi: 10.1016/j.clon.2017.11.010. Epub 2017 Dec 8. |
| 15537196 | Background | Ryu S, Rock J, Rosenblum M, Kim JH. Patterns of failure after single-dose radiosurgery for spinal metastasis. J Neurosurg. 2004 Nov;101 Suppl 3:402-5. |
| 17688054 | Background | Chang EL, Shiu AS, Mendel E, Mathews LA, Mahajan A, Allen PK, Weinberg JS, Brown BW, Wang XS, Woo SY, Cleeland C, Maor MH, Rhines LD. Phase I/II study of stereotactic body radiotherapy for spinal metastasis and its pattern of failure. J Neurosurg Spine. 2007 Aug;7(2):151-60. doi: 10.3171/SPI-07/08/151. |
| 17224814 | Background | Gerszten PC, Burton SA, Ozhasoglu C, Welch WC. Radiosurgery for spinal metastases: clinical experience in 500 cases from a single institution. Spine (Phila Pa 1976). 2007 Jan 15;32(2):193-9. doi: 10.1097/01.brs.0000251863.76595.a2. |
| 19092627 | Background | Wowra B, Zausinger S, Drexler C, Kufeld M, Muacevic A, Staehler M, Tonn JC. CyberKnife radiosurgery for malignant spinal tumors: characterization of well-suited patients. Spine (Phila Pa 1976). 2008 Dec 15;33(26):2929-34. doi: 10.1097/BRS.0b013e31818c680a. |
| 23167547 | Background | Expert Panel on Radiation Oncology-Bone Metastases; Lo SS, Lutz ST, Chang EL, Galanopoulos N, Howell DD, Kim EY, Konski AA, Pandit-Taskar ND, Rose PS, Ryu S, Silverman LN, Sloan AE, Van Poznak C. ACR Appropriateness Criteria (R) spinal bone metastases. J Palliat Med. 2013 Jan;16(1):9-19. doi: 10.1089/jpm.2012.0376. Epub 2012 Nov 20. |
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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