Status:
UNKNOWN
Involved Versus Elective Target SSRS for Spinal Metastases
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Secondary Malignant Neoplasm of Spine
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
The spine is a common metastatic site for malignancy and it can lead to serious and devastating events, including pain, neurological dysfunction, and reduction in quality of life. The radiotherapy (RT...
Detailed Description
Although conventionally fractionated radiation therapy has been utilized for decades, the rates of complete pain relief and local control for complex tumors are sub-optimal. The management of patients...
Eligibility Criteria
Inclusion
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 20 years
- Karnofsky performance status (KPS) ≥ 60%.
- Life expectancy of ≥ 6 month.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow- up schedules and provide study-specific informed consent
Exclusion
- Prior radiotherapy to the index spine(s)
- Serum creatinine \> 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with leptomeningeal involvement or intramedullary metastasis
- Inability to tolerate treatment procedure
- Bony retropulsion causing neurologic abnormality
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements
- Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04033536
Start Date
August 1 2019
End Date
June 1 2024
Last Update
July 26 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan