Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03392233
Eligibility Criteria:
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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03392233
Study Brief:
Protocol Section:
NCT03392233