RecruitingPhase 1Phase 2NCT04947280

Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer


Sponsor

Fudan University

Enrollment

120 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is evaluating a precise radiation technique called fractionated stereotactic radiation therapy (FSRT) — which delivers focused, high-dose radiation in multiple sessions — for treating bone metastases (cancer that has spread to the bones) in patients with breast cancer. **You may be eligible if...** - You have a confirmed diagnosis of invasive breast cancer - You have bone metastases confirmed by MRI within 4 weeks - Your tumor in the bone is at least 2mm away from the spinal cord (or has been surgically treated if closer) - You have no more than 3 separate spinal metastasis sites, and each involves no more than 2 adjacent vertebrae - You are in reasonably good health (KPS ≥40 or ECOG 0–2) - You have previously tried conventional radiation or surgery, or are unable to have surgery **You may NOT be eligible if...** - Your spine is structurally unstable or you have spinal cord compression that needs immediate treatment - You have a pacemaker or cannot lie flat for 30 minutes or cannot have an MRI - You have had prior radiation to the same spinal area within 3 months - You are pregnant - You have serious conditions like severe heart disease or end-stage kidney disease - You had chemotherapy within 2 weeks of starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONFractionated Stereotatic Radiation Therapy

Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT04947280


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