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

July 18, 2019 updated by: Peking University Third Hospital

Stereotactic Radiotherapy and Conventionally-fractionated-image-guided Intensity Modulated Radiotherapy for Spinal Metastatic Tumors：A Prospective Multicenter Cohort 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.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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • BeiJing, Beijing, China, 100000
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:
          • XueZhang Duan, M Med
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University Third Hospital
        • Contact:
        • Contact:
        • 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
    • Guangxi
      • NanNing, Guangxi, China, 530000
        • Recruiting
        • Guangxi Ruikang Hospital
    • Guizhou
      • GuiYang, Guizhou, China, 550000
        • Recruiting
        • Third Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Liaoning
      • Panjin, Liaoning, China, 124010
        • Recruiting
        • GEM flower hospital of Liaohe oil field Tang-Du Hospital
        • Contact:
          • Longhai Shen, M Med
        • Principal Investigator:
          • Long hai Shen, M Med
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Hiser Medical Center of Qingdao
        • Contact:
          • Peng Liu, M Med
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Qingdao chengyang people's hospital
        • Contact:
          • JanGuo Zhang, M Med
    • Shanxi
      • TaiYuan, Shanxi, China, 030000
        • Recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
        • Sub-Investigator:
          • Lei Zhang, M Med
      • Xian, Shanxi, China, 710000
        • Recruiting
        • Tangdu Hospital
        • Contact:
          • DongJie He, M Med
    • Sichuan
      • Mianyang, Sichuan, China, 621000
        • Recruiting
        • Mianyang Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaobo Du, MD
        • Sub-Investigator:
          • Jie Li, M Med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after the treatment
Muscle strength and muscle tension grading
Time Frame: 1 year after the treatment
Muscle strength and muscle tension were graded by Numbers
1 year after the treatment
JOA score of cervical and lumbar vertebrae
Time Frame: 2 years after the treatment
JOA score of cervical and lumbar vertebrae
2 years after the treatment
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.
2 years after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years after the treatment
The time from enrollment to death from any cause
3 years after the treatment
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
1 years after the treatment
Local control rate
Time Frame: 3 years after the treatment
The rate at which lesions remained stable during follow-up
3 years after the treatment
Adverse reactions
Time Frame: 6 months after the treatment
Adverse reactions during and after treatment
6 months after the treatment
Progression-free survival
Time Frame: 3 years after the treatment
Time from treatment to cancer progression or death
3 years after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Beijing 302 Hospital
Tang-Du Hospital
Second Hospital of Shanxi Medical University
Mianyang Central Hospital
Qingdao Hiser Medical Group
Guangxi Ruikang Hospital
Qingdao chengyang hospital
Third Affiliated Hospital of Guizhou Medical University
Panjin Liaohe Oilfield Gem Flower Hospital

Investigators

  • 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: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2019

Primary Completion (ANTICIPATED)

May 31, 2021

Study Completion (ANTICIPATED)

May 31, 2022

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (ACTUAL)

May 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BYSY-CKIMRT-SPNALM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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