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Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases
Sponsor: M.D. Anderson Cancer Center
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.
Official title: Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2017-01-18
Completion Date
2028-05-30
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
Spine Radiosurgery
Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively. Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction).
Questionnaires
Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires. Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up.
Locations (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, United States