Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Official title

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

Overview

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.

Detailed description

Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.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.

Interventions

• Radiation Stereotactic Body Radiation Therapy
  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

Primary outcome measures

• The rate of relieve pain [Time frame: One week after radiation to 2 years late]

Secondary outcome measures (3)

• The degree of relieve pain [Time frame: One week after radiation to 2 years late]
• The duration relieve pain [Time frame: One week after radiation to 2 years late]
• The incidence of toxicity [Time frame: One week after radiation to 2 years late]

Eligibility criteria

Inclusion criteria

• WHO scores 0-2;
• The primary lesion was confirmed by pathology or cytology;
• The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
• The metastatic lesion was limited in 3 consecutive vertebral bodies;
• The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;
• 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:

• Leukocytes ≥ 3.0 x109/ L;
• Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;
• Platelet count ≥ 100 x109/ L;
• Hemoglobin (Hb) ≥ 9g/ dL;
• Total bilirubin ≤1.5 x the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤ 3 x ULN;
• Aspartate aminotransferase (AST) ≤ 3 x ULN;
• Serum creatinine ≤ 1.5 x the ULN;
• Signed informed consent;

Exclusion criteria

• 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;
• There were >3 consecutive vertebral bodies involved;
• Spinal cord compression has occurred;
• The gap between tumor and spinal cord was less than 3mm;
• The metastatic area previously received radiation;
• Pregnant and Nursing women;
• Uncontrolled co-morbid illnesses;

9.refused to signed informed consent;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University — Shanghai

Identifiers

NCT: NCT03392233 · SBRT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗