Stereotactic Body Radiation Therapy for spinal metastases in certain cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the long-term outcomes of Stereotactic Body Radiation Therapy (SBRT) for patients with spinal metastases from breast cancer, prostate cancer, and non-small cell lung cancer. The study focuses on patients who are expected to survive more than two years and aims to assess the efficacy and safety of SBRT in providing pain relief and local control of metastatic lesions. Participants must meet specific eligibility criteria, including confirmed primary lesions and adequate organ function. The trial seeks to determine the benefits of SBRT in a selective patient population with a longer expected survival.

Why it matters

Who can join: the full rules

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;

Where it's running

• Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Ming Ye, Master — Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
• Study coordinator: Ming Ye, Master
• Email: renjiyeming@163.com
• Phone: +862168383459

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.