Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392233
• Other study ID #: SBRT-001
• 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
• 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;

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non Small Cell Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms

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