Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spi… (NCT03028337) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases
United States80 participantsStarted 2017-01-18
Plain-language summary
The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
✓. Age \>/=18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status \</=2 (Karnofsky \>/=60%)
✓. Life expectancy of greater than 6 months
✓. All patients must be able to lie supine
✓. All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
✓. All patients must have radiographic evidence of progression at a spinal site previously irradiated greater than 6 months prior to randomization. This includes indirect radiation exposure to spinal site.
✓. All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)2/2 of 42 Gy in a single session or 50 Gy cumulative over multiple sessions and cauda equina dose EQD2/2 of 50 Gy in a single session or 60 Gy cumulative over multiple session. EQD2/2 is calculated as follows: EQD2/2= biologically effective dose (BED)/(1+d/alpha beta)) where BED=nd(1+d/(alpha beta)) and n=number of fractions, d=dose per fraction and alpha beta ratio of 2.
Exclusion criteria
✕. Patients unable to undergo magnetic resonance imaging (MRI) of the spine
✕. Prior radiation at the site of interest within 6 months
What they're measuring
1
Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases
✕. Prior history of radiation at the site of interest resulting in a critical neural tissue dose of EQD2/2 of \>42 Gy in a single session
✕. Patients unable to lie flat comfortably for 2 hours
✕. Pregnancy status will be obtained at time of consent as is routine for all radiation patients. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects
✕. Patients with a histology of lymphoma and myeloma histologies