Actively Recruiting

Phase 2
Age: 18Years - 85Years
All Genders
NCT03392233

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Led by RenJi Hospital · Updated on 2018-01-05

100

Participants Needed

1

Research Sites

541 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

CONDITIONS

Official Title

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • WHO performance score between 0 and 2
  • Confirmed primary tumor diagnosis by pathology or cytology
  • Metastatic spinal lesions confirmed by imaging or biopsy
  • Metastases involve 3 or fewer consecutive vertebral bodies
  • Baseline pain score of 5 or higher with analgesic use recorded
  • Enhanced MRI scan of involved vertebrae within 2 weeks before radiotherapy
  • Adequate bone marrow, liver, and kidney function based on lab tests within 7 days before treatment
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Vertebral body shape changes with compression ≥ 50% or bone dissolution ≥ 50% risking serious bone events
  • More than 3 consecutive vertebral bodies involved
  • Spinal cord compression present
  • Distance between tumor and spinal cord less than 3mm
  • Prior radiation to the metastatic area
  • Pregnancy or nursing
  • Uncontrolled co-morbid illnesses
  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

M

Ming Ye, Master

CONTACT

Q

Qi Lu, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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