Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Phase 2

Recruiting

• Conditions: Prostate Cancer; Non Small Cell Lung Cancer; Breast Cancer
• Interventions: Radiation: Stereotactic Body Radiation Therapy

• Registration Number: NCT03392233
• Lead Sponsor: RenJi Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2017-08-18
• Status Verified: 2017-12
• Study First Submitted: 2017-12-31
• Study First Submitted QC: 2018-01-01
• Last Update Submitted: 2018-01-01
• Study First Posted: 2018-01-05
• Last Update Posted: 2018-01-05
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase II open lable Study	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

Name	Time	Method
The rate of relieve pain	One week after radiation to 2 years late	According to the Numerical Rating Pain Scale (NRPS)

Secondary Outcome Measures

Name	Time	Method
The duration relieve pain	One week after radiation to 2 years late	According to the Numerical Rating Pain Scale (NRPS)
The incidence of toxicity	One week after radiation to 2 years late	Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
The degree of relieve pain	One week after radiation to 2 years late	According to the Numerical Rating Pain Scale (NRPS)

Trial Locations

Locations (1)

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China