Status:
TERMINATED
Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Primary Tumor
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine how effective SBRT is compared to traditional radiation in treating the cancer that has spread to your spine and is causing pain. SBRT is delivered at a highe...
Detailed Description
Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in. You will have a 2 to 1 chance of be...
Eligibility Criteria
Inclusion
- Histologically confirmed primary tumor or metastatic cancer with radiological diagnosis of spine metastasis
- The patient must have localized spine metastasis from the C1 to L5 levels by a screening imaging study
- Zubrod Performance Status 0-2
- History/physical examination within 2 weeks prior to registration
- Negative pregnancy test within 2 weeks prior to registration for women of childbearing potential
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- MRI of the involved spine within 4 weeks prior to registration to determine the extent of the spine involvement
- Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of \>5 for at least one of the planned sites for spine radiosurgery. Patients taking medication for pain at the time of registration are eligible.
- Neurological examination within 1 week prior to registration to rule out rapid neurologic decline
Exclusion
- Histology of myeloma, lymphoma or germ cell tumors.
- Non-ambulatory patients
- Spine instability due to a compression fracture
- \> 50% loss of vertebral body height
- Frank spinal cord displacement or epidural involvement with\> 25% encirclement of cord or \>25% spinal canal involvement.
- Prior radiation to the index spine
- Patients for whom an MRI of the spine is medically contraindicated
- Uncontrolled intercurrent illness
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01525745
Start Date
January 1 2012
End Date
January 1 2014
Last Update
March 6 2017
Active Locations (3)
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1
Beth Israel Deacness Medical Center
Boston, Massachusetts, United States, 02215
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215