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

NCT03963713 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-19

No results posted yet for this study

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.

Conditions

  • Radiotherapy
  • Spine Metastases
  • Radiosurgery

Interventions

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.

Sponsors & Collaborators

  • Mianyang Central Hospital

    collaborator OTHER
  • Second Hospital of Shanxi Medical University

    collaborator OTHER
  • Qingdao chengyang hospital

    collaborator UNKNOWN
  • Qingdao Hiser Medical Group

    collaborator OTHER
  • Beijing 302 Hospital

    collaborator OTHER
  • Guangxi Ruikang Hospital

    collaborator OTHER
  • Third Affiliated Hospital of Guizhou Medical University

    collaborator UNKNOWN
  • Panjin Liaohe Oilfield Gem Flower Hospital

    collaborator OTHER
  • Tang-Du Hospital

    collaborator OTHER
  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Junjie Wang, MD · Peking University Third Hospital

  • Fei Xu, M Med · Peking University Third Hospital

  • Hongqing Zhuang, M Med · Peking University Third Hospital

  • Xiaobo Du, MD · Mianyang Central Hospital

  • Jie Li, M Med · Mianyang Central Hospital

  • Xiang Song, M Med · Second Hospital of Shanxi Medical University

  • Lei Zhang, M Med · Second Hospital of Shanxi Medical University

  • Jianguo Zhang, M Med · Qingdao chengyang people's hospital

  • Peng Liu, M Med · Qingdao Hiser Medical Group

  • Xuezhang Duan, MD · Beijing 302 Hospital

  • Zuping Lian, MD · Guangxi Ruikang Hospital

  • Liang Liu, MD · Third Affiliated Hospital of Guizhou Medical University

  • Longhai Shen, M Med · Panjin Liaohe Oilfield Gem Flower Hospital

  • Dongjie He, M Med · Tang-Du Hospital

  • Xuemin Li, MD · Peking University Third Hospital

  • Yi Chen, MD · Peking University Third Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2021-05-31
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963713 on ClinicalTrials.gov