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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03392233
Other study ID # SBRT-001
Secondary ID
Status Recruiting
Phase Phase 2
First received December 31, 2017
Last updated January 1, 2018
Start date August 18, 2017
Est. completion date December 31, 2027

Study information

Verified date December 2017
Source RenJi Hospital
Contact Ming Ye, Master
Phone +862168383459
Email renjiyeming@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2027
Est. primary completion date December 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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;

Study Design


Intervention

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

Locations

Country Name City State
China Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of relieve pain According to the Numerical Rating Pain Scale (NRPS) One week after radiation to 2 years late
Secondary The degree of relieve pain According to the Numerical Rating Pain Scale (NRPS) One week after radiation to 2 years late
Secondary The duration relieve pain According to the Numerical Rating Pain Scale (NRPS) One week after radiation to 2 years late
Secondary The incidence of toxicity Common Terminology Criteria for Adverse Events v3.0 (CTCAE) One week after radiation to 2 years late
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