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RecruitingNCT03392233Updated Jan 5, 2018

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

A Phase 2 interventional study of Stereotactic Body Radiation Therapy in Breast Cancer, Prostate Cancer and Non Small Cell Lung Cancer, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-05.

Sponsored by RenJi Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Prostate Cancer
  • Non Small Cell Lung Cancer

Keywords

  • spinal metastases
  • Stereotactic body radiation therapy(SBRT)
  • breast cancer
  • prostate cancer
  • non small cell lung cancer
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Phase II open lable Study

    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.

    Radiation: Stereotactic Body Radiation Therapy

Interventions

  • RadiationStereotactic 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

05

What researchers measure

Primary outcomes

  1. The rate of relieve pain

    According to the Numerical Rating Pain Scale (NRPS)

    Time frame: One week after radiation to 2 years late

Secondary outcomes

  1. The degree of relieve pain

    According to the Numerical Rating Pain Scale (NRPS)

    Time frame: One week after radiation to 2 years late

  2. The duration relieve pain

    According to the Numerical Rating Pain Scale (NRPS)

    Time frame: One week after radiation to 2 years late

  3. The incidence of toxicity

    Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

    Time frame: One week after radiation to 2 years late

06

Study locations

1 of 1 sites recruiting
  • Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200127, China
    • Ming Ye, Master · Contact · renjiyeming@163.com · +862168383459
    • Qi Lu, Master · Contact · luqi@renji.com · +862158752345
    • Ming Ye, Master · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03392233
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Jan 5, 2018
Start date
Aug 18, 2017
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jan 5, 2018

Study contacts

Ming Ye, Master
Contact
renjiyeming@163.com
+862168383459
Qi Lu, Master
Contact
luqi@renji.com
+8621-58752345 ext. 33364
Ming Ye, Master
principal investigator · Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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