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NCT Number: NCT03392233

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location status: Recruiting

Location contact

Ming Ye, Master

CONTACT

[email protected]

+862168383459

Ming Ye, Master

PRINCIPAL_INVESTIGATOR

Qi Lu, Master

CONTACT

[email protected]

+862158752345 ext. 33364

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Stereotactic Body Radiation Therapy

Radiation

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 outcomes

  1. The rate of relieve pain

    Time frame: One week after radiation to 2 years late

    According to the Numerical Rating Pain Scale (NRPS)

Secondary outcomes

  1. The degree of relieve pain

    Time frame: One week after radiation to 2 years late

    According to the Numerical Rating Pain Scale (NRPS)

  2. The duration relieve pain

    Time frame: One week after radiation to 2 years late

    According to the Numerical Rating Pain Scale (NRPS)

  3. The incidence of toxicity

    Time frame: One week after radiation to 2 years late

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Ye, Master

CONTACT

[email protected]

+862168383459

Qi Lu, Master

CONTACT

[email protected]

+8621-58752345 ext. 33364

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jan 5, 2018
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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