Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-25 @ 5:51 PM
Study NCT ID:
NCT03392233
Status:
RECRUITING
Last Update Posted:
2018-01-05
First Post:
2017-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Sponsor:
RenJi Hospital
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Status:
RECRUITING
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: