BridgeMD
New treatment option for Breast Cancer
Official title Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
ClinicalTrials.gov ID: NCT03392233
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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;
You likely can't join if
- 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...
- There were \>3 consecutive vertebral bodies involved;
- Spinal cord compression has occurred;
- The gap between tumor and spinal cord was less than 3mm;
- The metastatic area previously received radiation;
- Pregnant and Nursing women;
See the full eligibility criteria
- 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...
- 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;
- 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...
- There were \>3 consecutive vertebral bodies involved;
- Spinal cord compression has occurred;
- The gap between tumor and spinal cord was less than 3mm;
- The metastatic area previously received radiation;
- Pregnant and Nursing women;
- Uncontrolled co-morbid illnesses; 9.refused to signed informed consent;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.