Stereotactic Body Radiation Therapy for spinal metastases in certain cancers

A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

This study is testing if a special type of radiation therapy can help relieve pain and control cancer in patients with spinal tumors from breast, prostate, or lung cancer who are expected to live for more than two years.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT03392233 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with breast cancer, prostate cancer, or non-small cell lung cancer who have spinal metastases and are expected to survive more than two years.

Not a fit: Patients with a poor prognosis or those whose metastatic lesions exceed three consecutive vertebral bodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve pain management and local control of spinal metastases in patients with certain cancers.

How similar studies have performed: Other studies have shown promising results with Stereotactic Body Radiation Therapy for spinal metastases, indicating potential for success in this approach.

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;

Where this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Breast Cancer; Prostate Cancer; Non Small Cell Lung Cancer; spinal metastases; Stereotactic body radiation therapy; breast cancer; prostate cancer; non small cell lung cancer