Tests high-dose radiation for spinal cancer spread in breast, prostate or lung cancer
Tests focused radiation for spine tumors in adults with breast, prostate or lung cancer.
Plain-language title generated from the registry record
Registry title: Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT03392233, who can take part
Where in China
- Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of MedicineShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT03392233
- Record updated
- 5 January 2018
- Original description
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.Read full original descriptionShow less
A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
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.
Inclusion: WHO scores 0-2; The primary lesion was confirmed by pathology or cytology; The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy; The metastatic lesion was limited in 3 consecutive vertebral bodies; The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded; The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy; Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:; Leukocytes ≥ 3.0 x109/ L; Absolute neutrophil count (ANC) ≥ 1.5 x109/ L; Platelet count ≥ 100 x109/ L; Hemoglobin (Hb) ≥ 9g/ dL; Total bilirubin ≤1.5 x the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 x ULN; Aspartate aminotransferase (AST) ≤ 3 x ULN; Serum creatinine ≤ 1.5 x the ULN; Signed informed consent.
Exclusion: The metastatic area previously received radiation; Uncontrolled co-morbid illnesses; 9.refused to signed informed consent; There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed≥ 50%) or the vertebral body was unchanged but the volume of the dissolving bone was≥ 50% and could lead to serious bone adverse events; There were >3 consecutive vertebral bodies involved; Spinal cord compression has occurred; The gap between tumor and spinal cord was less than 3mm; Pregnant and Nursing women.