Clinical trial · Interventional
Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase II open lable Study
- description
- Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- The rate of relieve pain
- timeFrame
- One week after radiation to 2 years late
- description
- According to the Numerical Rating Pain Scale (NRPS)
Secondary outcomes (3)
- measure
- The degree of relieve pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. WHO scores 0-2; 2. The primary lesion was confirmed by pathology or cytology; 3. The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy; 4. The metastatic lesion was limited in 3 consecutive vertebral bodies; 5. The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded; 6. 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: 1. Leukocytes ≥ 3.0 x109/ L; 2. Absolute neutrophil count (ANC) ≥ 1.5 x109/ L; 3. Platelet count ≥ 100 x109/ L; 4. Hemoglobin (Hb) ≥ 9g/ dL; 5. Total bilirubin ≤1.5 x the upper limit of normal (ULN); 6. Alanine aminotransferase (ALT) ≤ 3 x ULN; 7. Aspartate aminotransferase (AST) ≤ 3 x ULN; 8. Serum creatinine ≤ 1.5 x the ULN; 9. Signed informed consent; Exclusion Criteria: 1. 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; 2. There were \>3 consecutive vertebral bodies involved; 3. Spinal cord compression has occurred; 4. The gap between tumor and spinal cord was less than 3mm; 5. The metastatic area previously received radiation; 6. Pregnant and Nursing women; 7. Uncontrolled co-morbid illnesses; 9.refused to signed informed consent;
References
Publications (0)
Data not yet available