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出境医 / 临床实验 / Stereotactic Radiotherapy and Image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors (SCIRSM)

Stereotactic Radiotherapy and Image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors (SCIRSM)

Study Description
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.

Condition or disease Intervention/treatment Phase
Radiotherapy Spine Metastases Radiosurgery Radiation: Stereotactic radiotherapy Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy Not Applicable

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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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).

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.
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.

Outcome Measures
Primary Outcome Measures :
  1. Cancer pain score [ Time Frame: 1 year after the treatment ]
    Numerical grading (NRS) should be used for pain intensity assessment, and facial expression pain scoring should be used for patients with difficulty in expression.

  2. Muscle strength and muscle tension grading [ Time Frame: 1 year after the treatment ]
    Muscle strength and muscle tension were graded by Numbers

  3. JOA score of cervical and lumbar vertebrae [ Time Frame: 2 years after the treatment ]
    JOA score of cervical and lumbar vertebrae

  4. Quality of Life Score of Tumor Patients(0-60) [ Time Frame: 2 years after the treatment ]
    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.


Secondary Outcome Measures :
  1. Duration of pain response [ Time Frame: 1 years after the treatment ]
    Time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS

  2. Overall survival [ Time Frame: 3 years after the treatment ]
    The time from enrollment to death from any cause

  3. Local control rate [ Time Frame: 3 years after the treatment ]
    The rate at which lesions remained stable during follow-up

  4. Adverse reactions [ Time Frame: 6 months after the treatment ]
    Adverse reactions during and after treatment

  5. Progression-free survival [ Time Frame: 3 years after the treatment ]
    Time from treatment to cancer progression or death


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80 years old;
  • Spine metastatic tumor patients confirmed by pathology and imaging; Number 3; Surgical treatment is not possible due to iatrogenic or (and) personal factors;
  • Spinal metastasis after previous systemic treatment or progression after previous treatment of spinal metastasis;
  • The anatomy of the spinal metastases form Tomita parting Ⅰ type - Ⅲ type; Without systemic metastasis or metastasis, the lesion was controlled.
  • ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
  • Expected survival 3 months;
  • Main organ function is good, without serious hypertension, diabetes and heart disease.
  • Has signed informed consent;
  • The compliance was good and the family members agreed to follow up for survival.

Exclusion Criteria:

  • Of the anatomy of the spinal metastases form Tomita classification: Ⅳ, Ⅴ Ⅵ, Ⅶ.
  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Junjie Wang, MD +860182264910 junjiewang_edu@sina.cn
Contact: Fei Xu, M Med +8618511866032 xufeibysy@163.com

Locations
Layout table for location information
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         
Sponsors and Collaborators
Peking University Third Hospital
Mianyang Central Hospital
Second Hospital of Shanxi Medical University
Qingdao chengyang hospital
Qingdao Hiser Medical Group
Beijing 302 Hospital
Guangxi Ruikang Hospital
Third Affiliated Hospital of Guizhou Medical University
Panjin Liaohe Oilfield Gem Flower Hospital
Tang-Du Hospital
Investigators
Layout table for investigator information
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
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
 (submitted: May 23, 2019)
  • Cancer pain score [ Time Frame: 1 year after the treatment ]
    Numerical grading (NRS) should be used for pain intensity assessment, and facial expression pain scoring should be used for patients with difficulty in expression.
  • Muscle strength and muscle tension grading [ Time Frame: 1 year after the treatment ]
    Muscle strength and muscle tension were graded by Numbers
  • JOA score of cervical and lumbar vertebrae [ Time Frame: 2 years after the treatment ]
    JOA score of cervical and lumbar vertebrae
  • Quality of Life Score of Tumor Patients(0-60) [ Time Frame: 2 years after the treatment ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Duration of pain response [ Time Frame: 1 years after the treatment ]
    Time from complete or partial pain relief to pain worsening (≥ 3 points on the NRPS
  • Overall survival [ Time Frame: 3 years after the treatment ]
    The time from enrollment to death from any cause
  • Local control rate [ Time Frame: 3 years after the treatment ]
    The rate at which lesions remained stable during follow-up
  • Adverse reactions [ Time Frame: 6 months after the treatment ]
    Adverse reactions during and after treatment
  • Progression-free survival [ Time Frame: 3 years after the treatment ]
    Time from treatment to cancer progression or death
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
Condition  ICMJE
  • Radiotherapy
  • Spine Metastases
  • Radiosurgery
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • 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

    Intervention: Radiation: Stereotactic radiotherapy
  • 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.
    Intervention: Radiation: Conventionally-fractionated image- guided Intensity modulated radiotherapy
Publications *
  • 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.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ® spinal bone metastases. J Palliat Med. 2013 Jan;16(1):9-19. doi: 10.1089/jpm.2012.0376. Epub 2012 Nov 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
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:

  • 18-80 years old;
  • Spine metastatic tumor patients confirmed by pathology and imaging; Number 3; Surgical treatment is not possible due to iatrogenic or (and) personal factors;
  • Spinal metastasis after previous systemic treatment or progression after previous treatment of spinal metastasis;
  • The anatomy of the spinal metastases form Tomita parting Ⅰ type - Ⅲ type; Without systemic metastasis or metastasis, the lesion was controlled.
  • ECOG physical condition score: 0-1, Karnofsky score 60, able to withstand puncture;
  • Expected survival 3 months;
  • Main organ function is good, without serious hypertension, diabetes and heart disease.
  • Has signed informed consent;
  • The compliance was good and the family members agreed to follow up for survival.

Exclusion Criteria:

  • Of the anatomy of the spinal metastases form Tomita classification: Ⅳ, Ⅴ Ⅵ, Ⅶ.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Junjie Wang, MD +860182264910 junjiewang_edu@sina.cn
Contact: Fei Xu, M Med +8618511866032 xufeibysy@163.com
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE
  • Mianyang Central Hospital
  • Second Hospital of Shanxi Medical University
  • Qingdao chengyang hospital
  • Qingdao Hiser Medical Group
  • Beijing 302 Hospital
  • Guangxi Ruikang Hospital
  • Third Affiliated Hospital of Guizhou Medical University
  • Panjin Liaohe Oilfield Gem Flower Hospital
  • Tang-Du Hospital
Investigators  ICMJE
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
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