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

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ClinicalTrials.gov Identifier: NCT03963713
Recruitment Status : Not yet recruiting
First Posted : May 27, 2019
Last Update Posted : May 27, 2019
Sponsor:
Collaborators:
Mianyang Central Hospital
Second Hospital of Shanxi Medical University
Qingdao chengyang hospital
Hiser Medical Center of Qingdao
The fifth medical center of PLA general hospital
Guangxi Ruikang Hospital
Third Affiliated Hospital of Guizhou Medical University
GEM flower hospital of Liaohe oil field
Tang-Du Hospital
Information provided by (Responsible Party):
Peking University Third Hospital

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.

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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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963713


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

Locations
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China, Beijing
Peking University Third Hospital Not yet 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 Not yet recruiting
BeiJing, Beijing, China, 100000
Contact: XueZhang Duan, M Med         
China, Guangxi
Guangxi ruikang hospital Not yet recruiting
NanNing, Guangxi, China, 530000
Contact: ZuPing Lian, M Med         
China, Guizhou
Third Affiliated Hospital of Guizhou Medical University Not yet 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 Not yet recruiting
Panjin, Liaoning, China, 124010
Contact: Longhai Shen, M Med         
Principal Investigator: Long hai Shen, M Med         
China, Shandong
Hiser Medical Center of Qingdao Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: Peng Liu, M Med         
Qingdao chengyang people's hospital Not yet recruiting
Qingdao, Shandong, China, 266000
Contact: JanGuo Zhang, M Med         
China, Shanxi
Second hospital of Shanxi Medical University Not yet recruiting
TaiYuan, Shanxi, China, 030000
Contact: Xiang Song, M Med       songxianggeryuan@163.cob   
Sub-Investigator: Lei Zhang, M Med         
Tangdu hospital Not yet recruiting
Xian, Shanxi, China, 710000
Contact: DongJie He, M Med         
China, Sichuan
Mianyang Central Hospital Not yet 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
Hiser Medical Center of Qingdao
The fifth medical center of PLA general hospital
Guangxi Ruikang Hospital
Third Affiliated Hospital of Guizhou Medical University
GEM flower hospital of Liaohe oil field
Tang-Du Hospital
Investigators
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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 Hiser Medical Center of Qingdao
Principal Investigator: Xuezhang Duan, MD The fifth medical center of PLA general 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 GEM flower hospital of Liaohe oil field
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

Publications:

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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03963713     History of Changes
Other Study ID Numbers: BYSY-CKIMRT-SPNALM
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Peking University Third Hospital:
Stereotactic radiotherapy
Intensity modulated radiotherapy
spinal metastatic tumors

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes