Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

NCT03392233 | Recruiting Phase 2

• 1 other identifier: SBRT-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The rate of relieve pain

  According to the Numerical Rating Pain Scale (NRPS)

  One week after radiation to 2 years late

Secondary Outcomes (3)

• The degree of relieve pain

  One week after radiation to 2 years late

• The duration relieve pain

  One week after radiation to 2 years late

• The incidence of toxicity

  One week after radiation to 2 years late

Study Arms (1)

Phase II open lable Study

EXPERIMENTAL

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

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

Phase II open lable Study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• refused to signed informed consent;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ming Ye, Master

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Ye, Master

CONTACT

+862168383459; renjiyeming@163.com

Qi Lu, Master

CONTACT

+8621-58752345; luqi@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 5, 2018
• Study Start: August 18, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 5, 2018

Record last verified: 2017-12

Locations

CN (1)