Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Launched by RENJI HOSPITAL · Jan 1, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a type of treatment called Stereotactic Body Radiation Therapy (SBRT) for patients with spinal tumors caused by breast cancer, prostate cancer, or non-small cell lung cancer. The goal is to see how well this treatment works in the long term, particularly in patients who are expected to live for more than two years. The trial aims to find out if SBRT can help relieve pain and control the growth of these tumors in the spine.

To participate, patients should be aged 65 or older and have a specific level of health as measured by a simple scoring system. They must have a confirmed diagnosis of their primary cancer and have spinal tumors limited to a certain area of their spine. Participants should also experience significant pain and have certain blood test results that show their organs are functioning well. However, some people will not be eligible, such as those with severe spinal issues or those who have already received radiation in the same area. If you join the trial, you can expect close monitoring and care while receiving this potentially beneficial treatment.

Gender

ALL

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;