Condition or disease | Intervention/treatment | Phase |
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Radiotherapy Spine Metastases Radiosurgery | Radiation: Stereotactic radiotherapy Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | non-randomized trial |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stereotactic Radiotherapy and Conventionally-fractionated-image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors:A Prospective Multicenter Cohort Study |
Actual Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | May 31, 2021 |
Estimated Study Completion Date : | May 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Stereotactic radiotherapy
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 |
Radiation: Stereotactic radiotherapy
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).
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Experimental: Conventionally-fractionated image- guided Intensity modulated
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.
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Radiation: 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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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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;
Contact: Junjie Wang, MD | +860182264910 | junjiewang_edu@sina.cn | |
Contact: Fei Xu, M Med | +8618511866032 | xufeibysy@163.com |
China, Beijing | |
Peking University Third Hospital | Recruiting |
Beijing, Beijing, China, 100000 | |
Contact: Junjie Wang, MD +8682264910 junjiewang_edu@sina.cn | |
Contact: Fei Xu, M Med +8618511866032 xufeibysy@163.com | |
Principal Investigator: Junjie Wang, MD | |
Sub-Investigator: Fei Xu, M Med | |
Sub-Investigator: Hongqing Zhuang, M Med | |
Sub-Investigator: Xuemin Li, MD | |
Sub-Investigator: Yi Chen, MD | |
The fifth medical center of PLA general hospital | Recruiting |
BeiJing, Beijing, China, 100000 | |
Contact: XueZhang Duan, M Med | |
China, Guangxi | |
Guangxi ruikang hospital | Recruiting |
NanNing, Guangxi, China, 530000 | |
Contact: ZuPing Lian, M Med | |
China, Guizhou | |
Third Affiliated Hospital of Guizhou Medical University | Recruiting |
GuiYang, Guizhou, China, 550000 | |
Contact: Liang Liu, M D jinshatanwo@163.com | |
China, Liaoning | |
GEM flower hospital of Liaohe oil field Tang-Du Hospital | Recruiting |
Panjin, Liaoning, China, 124010 | |
Contact: Longhai Shen, M Med | |
Principal Investigator: Long hai Shen, M Med | |
China, Shandong | |
Hiser Medical Center of Qingdao | Recruiting |
Qingdao, Shandong, China, 266000 | |
Contact: Peng Liu, M Med | |
Qingdao chengyang people's hospital | Recruiting |
Qingdao, Shandong, China, 266000 | |
Contact: JanGuo Zhang, M Med | |
China, Shanxi | |
Second hospital of Shanxi Medical University | Recruiting |
TaiYuan, Shanxi, China, 030000 | |
Contact: Xiang Song, M Med songxianggeryuan@163.cob | |
Sub-Investigator: Lei Zhang, M Med | |
Tangdu hospital | Recruiting |
Xian, Shanxi, China, 710000 | |
Contact: DongJie He, M Med | |
China, Sichuan | |
Mianyang Central Hospital | Recruiting |
Mianyang, Sichuan, China, 621000 | |
Contact: Xiaobo Du, MD +8613550822229 duxiaobo2005@126.com | |
Contact: Jie Li, M Med +8615228324561 lijie.7181@163.com | |
Principal Investigator: Xiaobo Du, MD | |
Sub-Investigator: Jie Li, M Med |
Study Chair: | Junjie Wang, MD | Peking University Third Hospital | |
Study Director: | Fei Xu, M Med | Peking University Third Hospital | |
Principal Investigator: | Hongqing Zhuang, M Med | 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 |
Tracking Information | |||||||||||||||||||||||||||||||||||||||||||||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
First Posted Date ICMJE | May 28, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
Last Update Posted Date | July 19, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
Actual Study Start Date ICMJE | June 10, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||||||||||||||
Change History | |||||||||||||||||||||||||||||||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||||||||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||||||||||||||||||||||||||
Brief Title ICMJE | Stereotactic Radiotherapy and Image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors | ||||||||||||||||||||||||||||||||||||||||||||||||
Official Title ICMJE | Stereotactic Radiotherapy and Conventionally-fractionated-image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors:A Prospective Multicenter Cohort Study | ||||||||||||||||||||||||||||||||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
Detailed Description | 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. | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Intervention Model Description: non-randomized trial Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Enrollment ICMJE |
100 | ||||||||||||||||||||||||||||||||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Study Completion Date ICMJE | May 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||
Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||||||||||||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||||||||||||||||||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||||||||||||||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT03963713 | ||||||||||||||||||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | BYSY-CKIMRT-SPNALM | ||||||||||||||||||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | ||||||||||||||||||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Peking University Third Hospital | ||||||||||||||||||||||||||||||||||||||||||||||||
Study Sponsor ICMJE | Peking University Third Hospital | ||||||||||||||||||||||||||||||||||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Peking University Third Hospital | ||||||||||||||||||||||||||||||||||||||||||||||||
Verification Date | May 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |