NCT03392233RecruitingPhase 2
Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors
Source: ClinicalTrials.gov · Last updated 5 Jan 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 31 Dec 2017
- Start date
- 18 Aug 2017
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Prostate cancer, Lung cancer
- NCT number
- NCT03392233
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 18 Aug 2017 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The metastatic area previously received radiation;
Other illness
- Uncontrolled co-morbid illnesses;
- 9.refused to signed informed consent;
Other
- 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;
- Pregnant and Nursing women;
Who the study is looking for
- 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;
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.