Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis

Stopped early · Phase 2

Conditions studied: Primary Tumor, Metastatic Cancer

In brief

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 higher dose for a shorter period of time when compared to standard radiation therapy and the aim is to see if there will be an improvement both in pain control and your cancer It is not known whether SBRT is better or worse than current standard therapy. If you are selected to receive the experimental treatment in this research study, SBRT uses highly focused x-rays that deliver a single high dose to a specific area of the spine compared to conventional standard radiation over a period of 10 days which has been the standard proven treatment to help your condition. The investigators will also determine which treatment provides the most rapid pain relief with the least side effects. It is possible that SBRT may not be better or could be more toxic. The investigators will conduct quality of life assessments and pain scale index to assess how you are feeling once you have had the intervention.

Key facts

Study ID

NCT01525745

Run by

Beth Israel Deaconess Medical Center

People needed

6

Starts

2012-01-01

Expected to finish

2014-01-01

Last updated by the study team

2017-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deacness Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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