Actively Recruiting
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
Led by Fudan University · Updated on 2021-07-01
120
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.
CONDITIONS
Official Title
Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of invasive breast cancer
- Signed informed consent
- Bone metastases confirmed by MRI within 4 weeks of enrollment
- Paraosseous soft tissue tumor size 5 cm or less
- Karnofsky Performance Status (KPS) 40 or higher or ECOG 0-2
- Tumor at least 2 mm away from the spinal cord or surgical resection prior to FSRT if closer
- Failure of previous conventional external beam radiotherapy or surgery, residual tumor after surgery, medical inoperability, or refusal of surgery
- Maximum of three distinct noncontiguous spinal metastases allowed, each may involve 2 contiguous vertebral bodies
- Adequate bone marrow, liver, and kidney function: neutrophil count 1500 cells/mm3 or more, platelet count 70000/mm3 or more, hemoglobin 8.0 g/dl or more, and if liver metastasis present, AST and ALT less than 3 times upper limit of normal
- At least 2 weeks since last systemic chemotherapy with side effects recovered to grade 1 or less
- Patients not receiving bisphosphonates, endocrine, or targeted therapy simultaneously
You will not qualify if you...
- Mechanically unstable spine or epidural spinal cord compression (except decompressed and stabilized cases)
- Loss of more than 50% vertebral body height
- Delay in treatment initiation that could harm neurological outcome
- Presence of pacemaker or inability to undergo MRI or lie flat for 30 minutes
- Previous radiotherapy to the spine at the current treatment level
- External-beam irradiation to the spine within 3 months prior to registration
- Systemic radiotherapy (Strontium-89) within 30 days before starting treatment
- Chemotherapy within 2 weeks before starting treatment
- Unwillingness or inability to attend regular follow-up
- Serious complications such as cardiovascular disease, end-stage renal disease, serious liver disease, infection
- Pregnancy
- Any other special conditions judged by researchers as exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhaozhi Yang, MD, Ph.D
CONTACT
W
Wei Shi, MD, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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